Pregabalin
Clinical data | |
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Pronunciation | /priˈɡæbəlɪn/ |
Trade names | Lyrica, others[1] |
Other names | 3-isobutyl GABA, (S)-3-isobutyl-γ-aminobutyric acid |
AHFS/Drugs.com | Monograph |
MedlinePlus | a605045 |
License data |
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Pregnancy category | |
GABA analog | |
ATC code | |
Legal status | |
Legal status | |
Pharmacokinetic data | |
Bioavailability | Oral: High (≥90% rapidly absorbed; food has no significant effect on bioavailability)[11] |
Protein binding | <1%[12] |
Metabolites | N-methylpregabalin[11] |
Onset of action | May occur within a week (pain)[13] |
Elimination half-life | 4.5–7 hours[14] (mean 6.3 hours)[14][15] |
Duration of action | Unknown[16] |
Excretion | Kidney |
Identifiers | |
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Pregabalin, sold under the brand name Lyrica among others, is an
Common side effects include headache,
Pregabalin was approved for medical use in the United States in 2004.
Medical uses
Seizures
For drug-resistant focal epilepsy, pregabalin is useful as an add-on therapy to other treatments.[35] Its use alone is less effective than some other seizure medications.[36] It is unclear how it compares to gabapentin for this use.[36]
Neuropathic pain
The European Federation of Neurological Societies recommends pregabalin as a first line agent for the treatment of pain associated with
Studies have shown that higher doses of pregabalin are associated with greater efficacy.[42]
Pregabalin's use in cancer-associated neuropathic pain is controversial,[43] though such use is common.[44] It has been examined for the prevention of post-surgical chronic pain, but its utility for this purpose is controversial.[45][46]
Pregabalin is generally not regarded as efficacious in the treatment of acute pain.[38] 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.[45][47] Several possible mechanisms for pain improvement have been discussed.[48]
Anxiety disorders
Pregabalin is effective for treatment of generalized anxiety disorder.[49] It is also effective for the short- and long-term treatment of social anxiety disorder and in reducing preoperative anxiety.[50][51] However, there is concern regarding pregabalin's off-label use due to the lack of strong scientific evidence for its efficacy in multiple conditions and its proven side effects.[52]
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
Generalized anxiety disorder
Pregabalin has
A 2019 review found that pregabalin reduces symptoms, and was generally well tolerated.[49]
Other uses
Although pregabalin is sometimes prescribed for people with bipolar disorder there is no evidence showing that it is effective.[51][59]
There is no evidence and significant risk in using pregabalin for sciatica and
There is no evidence for its use in the prevention of
Adverse effects
Exposure to pregabalin is associated with weight gain, sleepiness and fatigue, dizziness, vertigo, leg swelling, disturbed vision, loss of coordination, and euphoria.
- Very common (>10% of people with pregabalin): dizziness, drowsiness.
- Common (1–10% of people with pregabalin): blurred vision, asthenia, nasopharyngitis, increased creatine kinaselevel.
- Infrequent (0.1–1% of people with pregabalin): depression, lethargy, agitation, anorgasmia, hallucinations, kidney calculus
- Rare (<0.1% of people with pregabalin): neutropenia, first degree heart block, hypotension, hypertension, pancreatitis, dysphagia, oliguria, rhabdomyolysis, suicidal thoughts or behavior.[70]
Cases of recreational use, with associated adverse effects have been reported.[71]
Withdrawal symptoms
Following abrupt or rapid discontinuation of pregabalin, some people reported symptoms suggestive of
Pregnancy
It is unclear if it is safe for use in pregnancy with some studies showing potential harm.[73]
Breathing
In December 2019, the US Food and Drug Administration (FDA) warned about serious breathing issues for those taking gabapentin or pregabalin when used with CNS depressants or for those with lung problems.[74][75]
The FDA required new warnings about the risk of respiratory depression to be added to the prescribing information of the gabapentinoids.[74] The FDA also required the drug manufacturers to conduct clinical trials to further evaluate their abuse potential, particularly in combination with opioids, because misuse and abuse of these products together is increasing, and co-use may increase the risk of respiratory depression.[74]
Among 49 case reports submitted to the FDA over the five-year period from 2012 to 2017, twelve people died from respiratory depression with gabapentinoids, all of whom had at least one risk factor.[74]
The FDA reviewed the results of two randomized, double-blind, placebo-controlled clinical trials in healthy people, three observational studies, and several studies in animals.[74] One trial showed that using pregabalin alone and using it with an opioid pain reliever can depress breathing function.[74] The other trial showed gabapentin alone increased pauses in breathing during sleep.[74] The three observational studies at one academic medical center showed a relationship between gabapentinoids given before surgery and respiratory depression occurring after different kinds of surgeries.[74] The FDA also reviewed several animal studies that showed pregabalin alone and pregabalin plus opioids can depress respiratory function.[74]
Overdose
An overdose of pregabalin usually consists of severe drowsiness, severe ataxia, blurred vision and macular detachment,[76] slurred speech, severe uncontrollable jerking motions (myoclonus), tonic clonic seizures and anxiety.[77] Despite these symptoms an overdose is not usually fatal unless mixed with another depressant. Several people with kidney failure developed myoclonus while receiving pregabalin, apparently as a result of gradual accumulation of the drug. Acute overdosage may be manifested by somnolence, tachycardia and hypertonia. Plasma, serum or blood concentrations of pregabalin may be measured to monitor therapy or to confirm a diagnosis of poisoning in hospitalized people.[78][79][80]
Pharmacology
Interactions
No interactions have been demonstrated
Pharmacodynamics
Pregabalin is a
The
Pregabalin was found to possess 6-fold higher affinity than gabapentin for α2δ subunit-containing VDCCs in one study.[91][92] However, another study found that pregabalin and gabapentin had similar affinities for the human recombinant α2δ-1 subunit (Ki = 32 nM and 40 nM, respectively).[93] In any case, pregabalin is 2 to 4 times more potent than gabapentin as an analgesic[84][94] and, in animals, appears to be 3 to 10 times more potent than gabapentin as an anticonvulsant.[84][94]
Pharmacokinetics
Absorption
Pregabalin is
The
Distribution
Pregabalin crosses the blood–brain barrier and enters the central nervous system.[82] However, due to its low lipophilicity,[12] pregabalin requires active transport across the blood–brain barrier.[95][82][97][98] The LAT1 is highly expressed at the blood–brain barrier[99] and transports pregabalin across into the brain.[95][82][97][98] Pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating rats.[11] In humans, the volume of distribution of an orally administered dose of pregabalin is approximately 0.56 L/kg.[11] Pregabalin is not significantly bound to plasma proteins (<1%).[12]
Metabolism
Pregabalin undergoes little or no
Pregabalin is generally safe in patients with liver cirrhosis.[101]
Elimination
Pregabalin is
Chemistry
Pregabalin is a
Synthesis
Chemical syntheses of pregabalin have been described.[105][106]
History
External videos | |
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"Richard B. Silverman, Basic Science to Blockbuster Drug", National Academy of Inventors |
Pregabalin was synthesized in 1990 as an
Society and culture
Legal status
- United States: During clinical trials a small number of users (~4%) reported euphoria after use, which led to its control in the US.[114] 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.[115][66][116]
- Norway: Pregabalin is in prescription Schedule B, alongside benzodiazepines.[117][118]
- United Kingdom: On January 14, 2016, the Advisory Council on the Misuse of Drugs (ACMD) wrote a letter to Home Office ministers recommending that pregabalin alongside gabapentin should be controlled under the Misuse of Drugs Act 1971.[119][120] It was announced in October 2018, that Pregabalin would become reclassified as a class C controlled substance from April 2019.[121][34][122]
In the United States, the FDA has approved pregabalin for
Economics
Pregabalin is available as a
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.[127]
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,[128][129][130] 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.[128][129]
Intellectual property
Professor Richard "Rick" Silverman of Northwestern University developed pregabalin there. The university holds a patent on it, exclusively licensed to Pfizer.[131][132] 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.[133][134]
Pfizer's main patent for Lyrica, for seizure disorders, in the UK expired in 2013. In November 2018, the Supreme Court of the United Kingdom ruled that Pfizer's second patent on the drug, for treatment of pain, was invalid because there was a lack of evidence for the conditions it covered – central and peripheral neuropathic pain. From October 2015, GPs were forced to change people from generic pregabalin to branded until the second patent ran out in July 2017. This cost the NHS £502 million.[135]
Brand names
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, Lyribastad, Lyric, Lyrica, Lyrineur, Lyrolin, Lyzalon, Martesia, Maxgalin, Mystika, Neuragabalin, Neugaba, 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, Pregabid, Pregabin, Pregacent, Pregadel, Pregagamma, Pregalex, Pregalin, Pregalodos, 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.[136]
It was also marketed in several countries as a
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