|Trade names||Lyrica, others|
|Bioavailability||High (≥90% rapidly absorbed; administration with food has no significant effect on bioavailability)|
|Onset of action||may occur within a week (pain)|
|Biological half-life||6.3 to 11.5 hours|
|Duration of action||Unknown|
|Chemical and physical data|
|Molar mass||159.23 g.mol−1|
|3D model (JSmol)|
|(what is this?)|
Pregabalin, marketed under the brand name Lyrica among others, is a medication used to treat epilepsy, neuropathic pain, fibromyalgia, and generalized anxiety disorder. Its use for epilepsy is as an add-on therapy for partial seizures with or without secondary generalization in adults, some off-label uses of pregabalin include restless leg syndrome, prevention of migraines, social anxiety disorder, and alcohol withdrawal. When used before surgery it does not appear to affect pain after surgery but may decrease the use of opioids.
Common side effects include: sleepiness, confusion, trouble with memory, poor motor coordination, dry mouth, problem with vision, and weight gain. Potentially serious side effects include angioedema, drug misuse, and an increased suicide risk. When pregabalin is taken at high doses over a long period of time, addiction may occur, but if taken at usual doses the risk of addiction is low. Pregabalin is a gabapentinoid and acts by inhibiting certain calcium channels.
Parke-Davis developed pregabalin as a successor to gabapentin and was brought to market by Pfizer after the company acquired Warner-Lambert. There is to be no generic version available in the United States until 2018. A generic version is available in Canada, the United Kingdom, and Australia. In the US it costs about 300-400 USD per month. Pregabalin is a Schedule V controlled substance under the Controlled Substances Act of 1970 (CSA).
- 1 Medical uses
- 2 Side effects
- 3 Overdose
- 4 Drug interactions
- 5 Pharmacology
- 6 History
- 7 Society and culture
- 8 See also
- 9 References
- 10 External links
Pregabalin is useful when added to other treatments, when those other treatments are not controlling partial epilepsy, its use alone is less effective than some other seizure medications. It is unclear how it compares to gabapentin for this use.
The European Federation of Neurological Societies recommends pregabalin as a first line agent for the treatment of pain associated with diabetic neuropathy, post-herpetic neuralgia, and central neuropathic pain. A minority obtain substantial benefit, and a larger number obtain moderate benefit. Other first line agents, including gabapentin and tricyclic antidepressants, are given equal weight as first line agents, and unlike pregabalin, are available as less expensive generics.
Pregabalin is not recommended for certain other types of neuropathic pain such as trigeminal neuralgia and its use in cancer-associated neuropathic pain is controversial. There is no evidence for its use in the prevention of migraines and gabapentin has been found not to be useful, it has been examined for the prevention of post-surgical chronic pain, but its utility for this purpose is controversial.
Pregabalin is generally not regarded as efficacious in the treatment of acute pain; in trials examining the utility of pregabalin for the treatment of acute post-surgical pain, no effect on overall pain levels was observed, but people did require less morphine and had fewer opioid-related side effects. Several possible mechanisms for pain improvement have been discussed.
The World Federation of Biological Psychiatry recommends pregabalin as one of several first line agents for the treatment of generalized anxiety disorder, but recommends other agents such as SSRIs as first line treatment for obsessive-compulsive disorder and post-traumatic stress disorder. It appears to have anxiolytic effects similar to benzodiazepines with less risk of dependence.
The effects of pregabalin appear after 1 week of use and is similar in effectiveness to lorazepam, alprazolam, and venlafaxine, but pregabalin has demonstrated superiority by producing more consistent therapeutic effects for psychosomatic anxiety symptoms. Long-term trials have shown continued effectiveness without the development of tolerance, and, in addition, unlike benzodiazepines, it has a beneficial effect on sleep and sleep architecture, characterized by the enhancement of slow-wave sleep. It produces less severe cognitive and psychomotor impairment compared to those drugs; it also has a low potential for abuse and dependence and may be preferred over the benzodiazepines for these reasons.
Pregabalin has been shown to produce therapeutic effects that are similar to other controlled substances; in a study with recreational users of sedative and hypnotic drugs, a 450 mg dose of pregabalin resulted in subjective ratings of a "good drug effect" and "high" and "liking" similar to 30 mg of diazepam. In clinical studies, pregabalin showed a side effect profile similar to other central nervous system depressants.
- Very common (>10% of patients): dizziness, drowsiness.
- Common (1–10% of patients): blurred vision, diplopia, increased appetite and subsequent weight gain, euphoria, confusion, vivid dreams, changes in libido (increase or decrease), irritability, ataxia, attention changes, feeling high, abnormal coordination, memory impairment, tremors, dysarthria, parasthesia, vertigo, dry mouth and constipation, vomiting and flatulence, erectile dysfunction, fatigue, peripheral edema, feeling the effects of drunkenness, abnormal walking, asthenia, nasopharyngitis, increased creatine kinase level.
- Infrequent (0.1–1% of patients): depression, lethargy, agitation, anorgasmia, hallucinations, myoclonus, hypoaesthesia, hyperaesthesia, tachycardia, excessive salivation, hypoglycaemia, sweating, flushing, rash, muscle cramp, myalgia, arthralgia, urinary incontinence, dysuria, thrombocytopenia, kidney calculus
- Rare (<0.1% of patients): neutropenia, first degree heart block, hypotension, hypertension, pancreatitis, dysphagia, oliguria, rhabdomyolysis, suicidal thoughts or behavior.
Following abrupt or rapid discontinuation of pregabalin, some people reported symptoms suggestive of physical dependence, the FDA determined that the substance dependence profile of pregabalin, as measured by a patient physical withdrawal checklist, was quantitatively less than benzodiazepines. Even people who have discontinued short term and or long term use of pregabalin have experienced withdrawal symptoms, including insomnia, headache, nausea, anxiety, diarrhea, flu like symptoms, nervousness, major depression, pain, convulsions, hyperhidrosis and dizziness.
It is unclear if it is safe for use in pregnancy with some studies showing potential harm.
Several renal failure patients developed myoclonus while receiving pregabalin, apparently as a result of gradual accumulation of the drug. Acute overdosage may be manifested by somnolence, tachycardia and hypertonicity. Plasma, serum or blood concentrations of pregabalin may be measured to monitor therapy or to confirm a diagnosis of poisoning in hospitalized patients.
No interactions have been demonstrated in vivo, the manufacturer notes some potential pharmacological interactions with opioids, benzodiazepines, barbiturates, ethanol (alcohol), and other drugs that depress the central nervous system. ACE inhibitors may enhance the adverse/toxic effect of pregabalin. Pregabalin may enhance the fluid-retaining effect of anti-diabetic agents (Thiazolidinedione).
Pregabalin is a GABAergic anticonvulsant and depressant of the central nervous system (CNS). It is classified as a GABA analogue and gabapentinoid, it is a close analogue of the inhibitory neurotransmitter γ-aminobutyric acid (GABA). Pregabalin binds with high affinity to the α2δ subunit-containing voltage-gated calcium channels (VDCC). It increases extracellular GABA concentrations in the brain by producing a dose-dependent increase in L-Glutamic acid decarboxylase (GAD), the enzyme responsible for making GABA.
Although pregabalin is an analogue of GABA, it does not bind directly to GABAA, GABAB, GABAϱ, or benzodiazepine receptors. Nor does it block sodium channels and is not active at opioid receptors. Gabapentinoids, such as pregabalin, are α2δ subunit modifiers that affect GABA. In contrast to the distribution of α2δ-1 and α2δ-2 subunits binding correlates partially with GABAergic neurons. Pregabalin increases the density of GABA transporter proteins and increases the rate of functional GABA transport, it also increases extracellular GABA concentrations in the brain by producing a dose-dependent increase in L-Glutamic acid decarboxylase.
Pregabalin is rapidly absorbed when administered on an empty stomach, with peak plasma concentrations occurring within one hour. Pregabalin oral bioavailability is estimated to be greater than or equal to 90% and is independent of dose, the rate of pregabalin absorption is decreased when given with food resulting in a decrease in Cmax by approximately 25 to 30% and a delay in Tmax (time to reach Cmax) to approximately 3 hours. Administration with food, however, has no clinically significant effect on the extent of absorption.
Pregabalin has been shown to cross the blood–brain barrier in mice, rats, and monkeys. Pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating rats; in humans, the volume of distribution of pregabalin for an orally administered dose is approximately 0.56 L/kg and is not bound to plasma proteins.
Pregabalin undergoes negligible metabolism in humans; in experiments using nuclear medicine techniques, it was revealed that approximately 98% of the radioactivity recovered in the urine was unchanged pregabalin. The major metabolite is N-methylpregabalin.
|“Richard B. Silverman, Basic Science to Blockbuster Drug”, National Academy of Inventors|
Pregabalin was synthesized in 1990 as an anticonvulsant, it was invented by medicinal chemist Richard Bruce Silverman at Northwestern University in Evanston, Illinois. Silverman is best known for identifying the drug pregabalin as a possible treatment for epileptic seizures, during 1988 to 1990, Ryszard Andruszkiewicz, a visiting research fellow, synthesized a series of molecules for Silverman. One looked particularly promising, the molecule was effectively shaped for transportation into the brain, where it activated L-Glutamic acid decarboxylase, an enzyme. Silverman hoped that the enzyme would increase production of the inhibitory neurotransmitter GABA and block convulsions. Eventually, the set of molecules were sent to Parke-Davis Pharmaceuticals for testing, the drug was approved in the European Union in 2004. The US received FDA approval for use in treating epilepsy, diabetic neuropathic pain, and postherpetic neuralgia in December 2004. Pregabalin then appeared on the US market under the brand name Lyrica in fall of 2005.
Society and culture
In the United States as of 2015 the cost is between 3.69 and 5.52 USD per 150 mg capsule.
- United States: During clinical trials a small number of users (~4%) reported euphoria after use, which led to its control in the US. The Drug Enforcement Administration (DEA) classified pregabalin as a depressant and placed pregabalin, including its salts, and all products containing pregabalin into Schedule V of the Controlled Substances Act.
- Norway: Pregabalin is in prescription Schedule C, the lowest schedule, although it has been suggested that it be moved to Schedule B alongside benzodiazepines.
- United Kingdom: On January 14, 2016 the Advisory Council on the Misuse of Drugs (ACMD) wrote a letter to Home Office ministers recommending that both drugs be reclassified as a Class C drug and scheduled under the Misuse of Drugs Regulations 2001 (as amended) as Schedule 3. This would mean prescriptions would only be valid for one month and there can be no refills, the letter warns there is a risk of addiction for both drugs, as well as misuse and diversion. Recreational users of pregabalin in Belfast, Northern Ireland call the drug "Budweisers" because it induces a state similar to drunkenness.
In the United States, the Food and Drug Administration (FDA) has approved pregabalin for adjunctive therapy for adults with partial onset seizures, management of postherpetic neuralgia and neuropathic pain associated with spinal cord injury and diabetic peripheral neuropathy, and the treatment of fibromyalgia. Pregabalin has also been approved in the European Union and Russia (but not in US) for treatment of generalized anxiety disorder.
Since 2008, Pfizer has engaged in extensive direct-to-consumer advertising campaigns to promote its branded product Lyrica for fibromyalgia and diabetic nerve pain indications; in January 2016, the company spent a record amount, $24.6 million for a single drug on TV ads, reaching global revenues of $14 billion, more than half in the United States.
Up until 2009, Pfizer promoted Lyrica for other uses which had not been approved by medical regulators, for Lyrica and three other drugs, Pfizer was fined a record amount of US$2.3 billion by the Department of Justice, after pleading guilty to advertising and branding "with the intent to defraud or mislead." Pfizer illegally promoted the drugs, with doctors "invited to consultant meetings, many in resort locations; Attendees expenses were paid; they received a fee just for being there", according to prosecutor Michael Loucks.
Northwestern University invented pregabalin and holds a patent on it, which it exclusively licensed to Pfizer, that patent, along with others, was challenged by generic manufacturers and was upheld in 2014, giving Pfizer exclusivity for Lyrica in the US until 2018.
As of October 2017, pregabalin was marketed under many brand names in other countries: Algerika, Alivax, Alyse, Alzain, Andogablin, Aprion, Averopreg, Axual, Balifibro, Brieka, Clasica, Convugabalin, Dapapalin, Dismedox, Dolgenal, Dolica, Dragonor, Ecubalin, Epica, Epiron, Gaba-P, Gabanext, Gabarol, Gabica, Gablin, Gablovac, Gabrika, Gavin, Gialtyn, Glonervya, Helimon, Hexgabalin, Irenypathic, Kabian, Kemirica, Kineptia, Lecaent, Lingabat, Linprel, Lyric, Lyrica, Lyrineur, Lyrolin, Martesia, Maxgalin, Mystika, Neuragabalin, Neurega, Neurica, Neuristan, Neurolin, Neurovan, Neurum, Newrica, Nuramed, Paden, Pagadin, Pagamax, Painica, Pevesca, PG, Plenica, Pragiola, Prebalin, Prebanal, Prebel, Prebictal, Prebien, Prefaxil, Pregaba, Pregabalin, Pregabalina, Pregabaline, Prégabaline, Pregabalinum, Pregabateg, Pregaben, Pregabin, Pregacent, Pregadel, Pregagamma, Pregalex, Pregalin, Pregamid, Pregan, Preganerve, Pregastar, Pregatrend, Pregavalex, Pregdin Apex, Pregeb, Pregobin, Prejunate, Prelin, Preludyo, Prelyx, Premilin, Preneurolin, Prestat, Pretor, Priga, Provelyn, Regapen, Resenz, Rewisca, Serigabtin, Symra, Vronogabic, Xablin, and Xil.
It was also marketed in several countries as a combination drug with mecobalamin under the brand names Agemax-P, Alphamix-PG, Freenerve-P, Gaben, Macraberin-P, Mecoblend-P, Mecozen-PG, Meex-PG, Methylnuron-P, Nervolin, Nervopreg, Neurica-M, Neuroprime-PG, Neutron-OD, Nuroday-P, Nurodon-PG, Nuwin-P, Pecomin-PG, Prebel-M, Predic-GM, Pregacent-M, Pregamet, Preganerv-M, Pregeb-M OD, Pregmic, Prejunate Plus, Preneurolin Plus, Pretek-GM, Rejusite, Renerve-P, Safyvit-PR, and Vitcobin-P, Voltanerv with Methylcobalamin and ALA by Cogentrix Pharma.
- Schifano, Fabrizio (2014). "Misuse and Abuse of Pregabalin and Gabapentin: Cause for Concern?". CNS Drugs. 28 (6): 491–6. doi:10.1007/s40263-014-0164-4. PMID 24760436.
- "Pregabalin - Drugs.com". www.drugs.com. Retrieved 2016-11-07.
- "Summary of product characteristics" (PDF). European Medicines Agency. 6 March 2013. Retrieved 6 May 2013.
- "Pregabalin (Professional Patient Advice) - Drugs.com". www.drugs.com. Retrieved 2016-11-07.
- "Pregabalin (Professional Patient Advice)". Drugs.com.
- Hantson, P; Courtois, F; Borrey, D; Haufroid, V (2014). "Pregabalin-associated myoclonic encephalopathy without evidence of drug accumulation in a patient with acute renal failure". Indian Journal of Nephrology. 24 (1): 48–50. doi:10.4103/0971-4065.125102. PMC . PMID 24574633.
- Randinitis, Edward J.; Posvar, Edward L.; Alvey, Christine W.; Sedman, Allen J.; Cook, Jack A.; Bockbrader, Howard N. (2003). "Pharmacokinetics of Pregabalin in Subjects with Various Degrees of Renal Function". The Journal of Clinical Pharmacology. 43 (3): 277–83. doi:10.1177/0091270003251119. PMID 12638396.
- Lilley, Linda Lane; Collins, Shelly Rainforth; Snyder, Julie S. (2015). Pharmacology and the Nursing Process. Elsevier Health Sciences. p. 227. ISBN 9780323358286.
- Frampton, James E. (2014). "Pregabalin: A Review of its Use in Adults with Generalized Anxiety Disorder". CNS Drugs. 28 (9): 835–54. doi:10.1007/s40263-014-0192-0. PMID 25149863.
- "Pregabalin". The American Society of Health-System Pharmacists. Retrieved Oct 23, 2015.
- Patel, Ryan; Dickenson, Anthony H. (2016). "Mechanisms of the gabapentinoids and α2δ-1 calcium channel subunit in neuropathic pain". Pharmacology Research & Perspectives. 4 (2): e00205. doi:10.1002/prp2.205. PMC . PMID 27069626.
- Benkert, Otto; Hippius, Hanns (2006). Kompendium Der Psychiatrischen Pharmakotherapie (in German) (6th ed.). Springer. ISBN 978-3-540-34401-8.
- Douglas Kirsch (10 October 2013). Sleep Medicine in Neurology. John Wiley & Sons. p. 241. ISBN 978-1-118-76417-6.
- "Pregabalin (Lyrica®):Part I". October 2005. Retrieved 7 August 2016.
- Mirijello, Antonio; Caputo, Fabio; Vassallo, Gabriele; Rolland, Benjamin; Tarli, Claudia; Gasbarrini, Antonio; Addolorato, Giovanni (2015). "GABAB Agonists for the Treatment of Alcohol Use Disorder". Current Pharmaceutical Design. 21 (23): 3367–72. doi:10.2174/1381612821666150619091858. PMID 26088121.
- Arora, MaheshKumar; Agarwal, Anil; Baidya, DalimKumar; Khanna, Puneet (2011). "Pregabalin in acute and chronic pain". Journal of Anaesthesiology Clinical Pharmacology. 27 (3): 307–14. doi:10.4103/0970-9185.83672. PMC . PMID 21897498.
- Calandre EP, Rico-Villademoros F, Slim M (2016). "Alpha2delta ligands, gabapentin, pregabalin and mirogabalin: a review of their clinical pharmacology and therapeutic use". Expert Rev Neurother. 16 (11): 1263–1277. doi:10.1080/14737175.2016.1202764. PMID 27345098.
- Uchitel OD, Di Guilmi MN, Urbano FJ, Gonzalez-Inchauspe C (2010). "Acute modulation of calcium currents and synaptic transmission by gabapentinoids". Channels (Austin). 4 (6): 490–6. doi:10.4161/chan.4.6.12864. PMID 21150315.
- Jensen B, Regier LD, editors. RxFiles : Drug comparison charts. 7th ed. Saskatoon, SK: RxFiles, 2010; p.78
- Baillie, JK; Power, I (2006). "The mechanism of action of gabapentin in neuropathic pain". Current Opinion in Investigational Drugs. 7 (1): 33–9. PMID 16425669.
- Decker, Susan. "Pfizer Wins Ruling to Block Generic Lyrica Until 2018". Bloomberg.com. Retrieved 7 June 2016.
- "Off to a running start? Federal Court of Australia permits generic manufacturer to make PBS application before patent expiry - IP Whiteboard | King & Wood Mallesons". IP Whiteboard. 28 April 2017. Retrieved 28 November 2017.
- Roland, Denise (10 September 2015). "Pfizer Loses U.K. Patent Case Over Lyrica". Wall Street Journal. Retrieved 7 June 2016.
- "Pregabalin During Pregnancy May Be Linked To Birth Defects". ReliaWire. 19 May 2016. Retrieved 7 June 2016.
- Pulman, Jennifer; Hemming, Karla; Marson, Anthony G; Pulman, Jennifer (2014). "Pregabalin add-on for drug-resistant partial epilepsy". The Cochrane Database of Systematic Reviews (3): CD005612. doi:10.1002/14651858.CD005612.pub3. PMID 24623260.
- Zhou, Q; Zheng, J; Yu, L; Jia, X (17 October 2012). "Pregabalin monotherapy for epilepsy". The Cochrane Database of Systematic Reviews. 10: CD009429. doi:10.1002/14651858.CD009429.pub2. PMID 23076957.
- Attal N, Cruccu G, Baron R, et al. (September 2010). "EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision". Eur. J. Neurol. 17 (9): 1113–e88. doi:10.1111/j.1468-1331.2010.02999.x. PMID 20402746.
- Moore, R Andrew; Straube, Sebastian; Wiffen, Philip J; Derry, Sheena; McQuay, Henry J; Moore, Maura (2009). "Pregabalin for acute and chronic pain in adults". The Cochrane Database of Systematic Reviews (3): CD007076. doi:10.1002/14651858.CD007076.pub2. PMC . PMID 19588419.
- Finnerup, NB; Sindrup SH; Jensen TS (September 2010). "The evidence for pharmacological treatment of neuropathic pain". Pain. 150 (3): 573–81. doi:10.1016/j.pain.2010.06.019. PMID 20705215.
- Bennett, Michael I.; Laird, Barry; van Litsenburg, Chantal; Nimour, Meryem (2013). "Pregabalin for the Management of Neuropathic Pain in Adults with Cancer: A Systematic Review of the Literature". Pain Medicine. 14 (11): 1681–8. doi:10.1111/pme.12212. PMID 23915361.
- Linde, M; Mulleners, WM; Chronicle, EP; McCrory, DC (Jun 24, 2013). "Gabapentin or pregabalin for the prophylaxis of episodic migraine in adults". The Cochrane Database of Systematic Reviews. 6 (6): CD010609. doi:10.1002/14651858.CD010609. PMID 23797675.
- Clarke H, Bonin RP, Orser BA, Englesakis M, Wijeysundera DN, Katz J (August 2012). "The prevention of chronic postsurgical pain using gabapentin and pregabalin: a combined systematic review and meta-analysis". Anesth. Analg. 115 (2): 428–42. doi:10.1213/ANE.0b013e318249d36e. PMID 22415535.
- Chaparro, Luis Enrique; Smith, Shane A; Moore, R Andrew; Wiffen, Philip J; Gilron, Ian; Gilron, Ian (2013). "Pharmacotherapy for the prevention of chronic pain after surgery in adults". The Cochrane Database of Systematic Reviews (7): CD008307. doi:10.1002/14651858.CD008307.pub2. PMID 23881791.
- Hamilton, TW; Strickland, LH; Pandit, HG (17 August 2016). "A Meta-Analysis on the Use of Gabapentinoids for the Treatment of Acute Postoperative Pain Following Total Knee Arthroplasty". The Journal of Bone and Joint Surgery. American Volume. 98 (16): 1340–50. doi:10.2106/jbjs.15.01202. PMID 27535436.
- Wensel TM, Powe KW, Cates ME (March 2012). "Pregabalin for the treatment of generalized anxiety disorder". Ann Pharmacother. 46 (3): 424–9. doi:10.1345/aph.1Q405. PMID 22395254.
- Owen, Richard T. (September 2007). "Pregabalin: its efficacy, safety and tolerability profile in generalized anxiety". Drugs of Today. 43 (9): 601–10. doi:10.1358/dot.2007.43.9.1133188. PMID 17940637. Retrieved 2012-01-22.
- Bandelow B, Sher L, Bunevicius R, et al. (June 2012). "Guidelines for the pharmacological treatment of anxiety disorders, obsessive-compulsive disorder and posttraumatic stress disorder in primary care". Int J Psychiatry Clin Pract. 16 (2): 77–84. doi:10.3109/13651501.2012.667114. PMID 22540422.
- Bandelow, Borwin; Wedekind, Dirk; Leon, Teresa (2007). "Pregabalin for the treatment of generalized anxiety disorder: a novel pharmacologic intervention". Expert Review of Neurotherapeutics. 7 (7): 769–81. doi:10.1586/14737126.96.36.1999. PMID 17610384.
- Owen, R.T. (2007). "Pregabalin: Its efficacy, safety and tolerability profile in generalized anxiety". Drugs of Today. 43 (9): 601–10. doi:10.1358/dot.2007.43.9.1133188. PMID 17940637.
- Shanthanna, Harsha; Gilron, Ian; Rajarathinam, Manikandan; AlAmri, Rizq; Kamath, Sriganesh; Thabane, Lehana; Devereaux, Philip J.; Bhandari, Mohit; Tsai, Alexander C. (15 August 2017). "Benefits and safety of gabapentinoids in chronic low back pain: A systematic review and meta-analysis of randomized controlled trials". PLOS Medicine. 14 (8): e1002369. doi:10.1371/journal.pmed.1002369.
- Drug Enforcement Administration, Department of Justice (July 2005). "Schedules of controlled substances: placement of pregabalin into schedule V. Final rule". Federal Register. 70 (144): 43633–5. PMID 16050051. Retrieved 2012-01-22.
- Pfizer Australia Pty Ltd. Lyrica (Australian Approved Product Information). West Ryde: Pfizer; 2006.
- Rossi, Simone, ed. (2006). Australian Medicines Handbook, 2006. Australian Medicines Handbook. ISBN 978-0-9757919-2-9.[page needed]
- "Medication Guide (Pfizer Inc.)" (PDF). U.S. Food and Drug Administration. June 2011. Retrieved 2011-11-06.
- "Lyrica Capsules". medicines.org.uk.
- "Pregabalin Pregnancy and Breastfeeding Warnings". Retrieved 29 August 2016.
- Murphy, N.G.; Mosher, L. (2008). "Severe myoclonus from pregabalin (Lyrica) due to chronic renal insufficiency". Clinical Toxicology. 46 (7): 594. doi:10.1080/15563650802255033.
- Yoo, Lawrence; Matalon, Daniel; Hoffman, Robert S.; Goldfarb, David S. (2009). "Treatment of pregabalin toxicity by hemodialysis in a patient with kidney failure". American Journal of Kidney Diseases. 54 (6): 1127–30. doi:10.1053/j.ajkd.2009.04.014. PMID 19493601.
- Baselt, Randall C. (2008). Disposition of Toxic Drugs and Chemicals in Man (8th ed.). Biomedical Publications. pp. 1296–1297. ISBN 978-0-9626523-7-0.
- Pregabalin. In: Lexi-Drugs [database on the Internet]. Hudson (OH): Lexi-Comp, Inc.; 2007 [cited 2015 Oct 29].
- https://www.drugs.com/drug-class/gamma-aminobutyric-acid-analogs.html[full citation needed]
- Bryans, Justin S.; Wustrow, David J. (1999). "3-Substituted GABA analogs with central nervous system activity: A review". Medicinal Research Reviews. 19 (2): 149–77. doi:10.1002/(SICI)1098-1128(199903)19:2<149::AID-MED3>3.0.CO;2-B. PMID 10189176.
- https://pubchem.ncbi.nlm.nih.gov/compound/5486971[full citation needed]
- Lapin, Izyaslav (2001). "Phenibut (β-Phenyl-GABA): A Tranquilizer and Nootropic Drug". CNS Drug Reviews. 7 (4): 471–81. doi:10.1111/j.1527-3458.2001.tb00211.x. PMID 11830761.
- https://books.google.com/books?id=Zgx13oMZaYUC&pg=PA88&[full citation needed]
- https://www.researchgate.net/publication/237837376_Pregabalin_is_a_potent_and_selective_ligand_for_alpha2delta-1_and_alpha2delta-2_calcium_channel_subunits[full citation needed]
- Sze, PY (1979). "L-Glutamate decarboxylase". Advances in Experimental Medicine and Biology. 123: 59–78. doi:10.1007/978-1-4899-5199-1_4. PMID 390996.
- Dolphin, Annette C. (2012). "Calcium channel auxiliary α2δ and β subunits: trafficking and one step beyond". Nature Reviews Neuroscience. 13 (8): 542–55. doi:10.1038/nrn3311. PMID 22805911. Errata is: Dolphin, Annette C. (2012). "Calcium channel auxiliary α2δ and β subunits: trafficking and one step beyond". Nature Reviews Neuroscience. 13 (9): 664. doi:10.1038/nrn3317.
- DBA Quality Care Products LLC, Lake Erie Medical. "LYRICA 200 mg". DailyMed. Lake Eric Medical DBA Quality Care Products LLC. Retrieved 27 September 2015.
- Lauria-Horner, Bianca A; Pohl, Robert B (2003). "Pregabalin: a new anxiolytic". Expert Opinion on Investigational Drugs. 12 (4): 663–72. doi:10.1517/135437188.8.131.523. PMID 12665421.
- http://www.clevelandclinicmeded.com/medicalpubs/pharmacy/septoct2005/pregabalin.htm[full citation needed]
- McMahon, Stephen B (2013). Wall and Melzack's textbook of pain (6th ed.). Philadelphia, PA: Elsevier/Saunders. p. 515. ISBN 9780702040597.
- McElroy, Susan L.; Keck, Paul E.; Post, Robert M., eds. (2008). Antiepileptic Drugs to Treat Psychiatric Disorders. INFRMA-HC. p. 370. ISBN 978-0-8493-8259-8.
- "LYRICA – pregabalin capsule". DailyMed. U.S. National Library of Medicine. September 2010. Retrieved 6 May 2013.
- Lowe, Derek. "Getting To Lyrica". In The Pipeline. Science. Retrieved 21 November 2015.
- Merrill, Nick (February 25, 2010). "Silverman's golden drug makes him NU's golden ticket". North by Northwestern. Retrieved 19 May 2016.
- Andruszkiewicz, Ryszard; Silverman, Richard B. (1990). "4-Amino-3-alkylbutanoic acids as substrates for gamma-aminobutyric acid aminotransferase". The Journal of Biological Chemistry. 265 (36): 22288–91. PMID 2266125.
- Poros, Joanna (2005). "Polish scientist is the co-author of a new anti-epileptic drug". Science and Scholarship in Poland. Retrieved 19 May 2016.
- Dworkin, Robert H.; Kirkpatrick, Peter (2005). "Pregabalin". Nature Reviews Drug Discovery. 4 (6): 455–6. doi:10.1038/nrd1756. PMID 15959952.
- Langreth, Robert (June 29, 2016). "Decoding Big Pharma's Secret Drug Pricing Practices". Bloomberg. Retrieved 15 July 2016.
- "Lyrica - FDA prescribing information, side effects and uses".
- Drug Enforcement Administration, Department of Justice (July 2005). "Schedules of controlled substances: placement of pregabalin into schedule V. Final rule". Fed Regist. 70 (144): 43633–5. PMID 16050051.
- "Title 21 CFR - PART 1308 - Section 1308.15 Schedule V". usdoj.gov.
- http://www.deadiversion.usdoj.gov/fed_regs/rules/2005/fr0728.htm[full citation needed]
- Felleskatalogen (7 May 2015). "Lyrica". felleskatalogen.no.
- Chalabianloo, F; Schjøtt J (January 2009). "Pregabalin and its potential for abuse". Journal of the Norwegian Medical Association. 129 (3): 186–187. doi:10.4045/tidsskr.08.0047. PMID 19180163.
- Anson, Pat (January 31, 2016). "Lyrica and Neurontin Face UK Restrictions". Pain News Network.
- Price, Caroline (26 January 2016). "Government told to restrict gabapentin and pregabalin availability". Pulse Today.
- "Letter to Minister for Preventing Abuse and Exploitation re Pregabalin and Gabapentin advice" (PDF). Advisory Council on the Misuse of Drugs. 14 January 2016.
- "Pfizer to pay $2.3 billion to resolve criminal and civil health care liability relating to fraudulent marketing and the payment of kickbacks". Stop Medicare Fraud, US Dept of Health & Human Svc, and of Justice. Retrieved 2012-07-04.
- "Pfizer's Lyrica Approved for the Treatment of Generalized Anxiety Disorder (GAD) in Europe" (Press release). Retrieved 2011-11-06.
- B. Snyder Bulik (March 2016). "AbbVie's Humira, Pfizer's Lyrica kick off 2016 with hefty TV ad spend". FiercePharma. Retrieved 5 March 2017.
- "Pfizer Pays $2.3 Billion to Settle Marketing Case". New York Times. Retrieved December 21, 2017.
- "Pfizer agrees record fraud fine". BBC News. September 2, 2009. Retrieved December 21, 2017.
- "Portions of the Pfizer Inc. 2010 Financial Report". U.S. Securities and Exchange Commission. 2010. Retrieved December 21, 2017.
- Jacoby, M. (2008). "Financial Windfall from Lyrica". Chemical & Engineering News. 86 (10): 56–61. doi:10.1021/cen-v086n010.p056.
- "Patent US6197819 - Gamma amino butyric acid analogs and optical isomers".
- Susan Decker for Bloomberg News. Feb 6, 2014. Pfizer Wins Ruling to Block Generic Lyrica Until 2018
- "Decision: Pfizer Inc. (PFE) v. Teva Pharmaceuticals USA Inc., 12-1576, U.S. Court of Appeals for the Federal Circuit (Washington)" (PDF).
- "Pregabalin international brands". Drugs.com. Retrieved 27 October 2017.
- LYRICA® (pregabalin) CV | Safety Info, Pfizer's website
- U.S. prescribing information
- Lyrica (pregabalin)[dead link] drug label/data at Daily Med from U.S. National Library of Medicine, National Institutes of Health.
- Lyrica Oral – Uses, Side Effects, Interactions, Pictures, Warnings & Dosing, information at WebMD
- Erowid Pregabalin (Lyrica) Vault
- The Pill That Made Northwestern Rich, report at Bloomberg Businessweek