Pregabalin

ArticlesMedicine Compliance Aid StabilityLactation Safety InformationNew Medicines ·
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Articles

Medicine Compliance Aid Stability

LyricaPfizer Ltd

Pfizer Ltd
Lyrica
Capsules 25mg, 50mg, 75mg, 100mg, 150mg, 225mg, 300mg,
A2 · Amber 2No stability data is available, the manufacturer does not, or cannot recommend use in CAs but there are no theoretical concerns with the product.
No special precautions for storage
No special requirements for storage.
9 February 2015

Lactation Safety Information

For epilepsy

For epilepsy
Gabapentin
No adverse effects reported in breastfed infants
Very limited published evidence of safety
Single case report of low serum levels in breastfed infant
17 April 2018

New Medicines

LyricaPartial onset seizures in children - adjunctive therapy

Information

Lyrica
Licence extension / variation
Upjohn UK
Pfizer

Development and Regulatory status

Not recommended for approval (Negative opinion)
Not recommended for approval (Negative opinion)
Launched
Nov 20Lyrica has been approved in the US for adjunctive therapy for the treatment of partial-onset seizures in patients 4 years of age and older since May 18, and from 1 month and older since May 19 [8].
Sep 20EU CHMP recommend a change to the SmPC for Lyrica but does not recommend approval of an indication change. Section 4.8 and Section 5.1 of the SmPC will be updated to reflect safety results from study A0081106 (NCT01463306). The licensed indications will remain treatment of peripheral and central neuropathic pain in adults, adjunctive therapy in adults with partial seizures with or without secondary generalisation, and treatment of generalised anxiety disorder in adults [7].
May 19The Lyrica Pediatric Epilepsy Program is composed of six studies in patients with epilepsy evaluating Lyrica as adjunctive therapy, five of which have been completed. They include PERIWINKLE (NCT01389596), NCT01463306, NCT01747915, NCT00437281, NCT00437281 and NCT02072824 [6].
Dec 16PIII trials underway [1]

Category

GABA receptor agonist
Epilepsy is about twice as common in children as in adults (about 700 per 100,000 in children under the age of 16 years compared to 330 per 100,000 in adults) [2].
Partial onset seizures in children - adjunctive therapy
Oral

Trial or other data

Nov 19PIII PERIWINKLE trial (NCT01389596), in which primary endpoints were met for the 10mg/kg/day dose, recruited 295 patients (see also entry from Dec 16) [5].
Aug 19PIII trial to evaluate the long-term efficacy and tolerability of pregabalin as an add-on therapy in paediatric patients with partial onset seizures and paediatric and adult patients with primary generalised tonic-clonic seizures completes (NCT01463306) [5].
May 19Pfizer announce that PIII trial (NCT01747915) of pregabalin as adjunctive therapy for epilepsy in children with primary generalized tonic-clonic (PGTC) seizures did not meet its primary endpoint. The trial was run at 70 sites in 21 countries with 219 patients. Pts receiving Lyrica did not show a statistically significant reduction in seizure frequency compared to placebo. The study was a post-marketing commitment to the FDA. Patients were randomised in a 1:1:1 ratio to receive placebo, or one of two fixed doses of Lyrica twice daily: 5 mg/kg/day (7 mg/kg/day for subjects with body weight <30 kg, and 300 mg/day for those 17 years of age and older) or 10 mg/kg/day (14 mg/kg/day for subjects with body weight <30 kg, and 600 mg/day for those 17 years of age and older) [4,6].
May 18Pfizer reports that the primary endpoint endpoint was met in PIII trial (NCT02072824). A 14 mg/kg/day dose resulted in a statistically significant reduction in seizure frequency versus placebo. Data further demonstrated that a lower dose of 7 mg/kg/day did not result in a statistically significant reduction in seizure frequency versus placebo. Safety profile of pregabalin was similar to that observed in earlier trials [5].
Mar 18Pfizer completes a PIII trial in partial epilepsies, adjunctive treatment, in infants & children (NCT02072824) [3].
Dec 16Pfizer announces 12-week placebo-controlled PIII trial (n=295) of Lyrica capsules and oral solution meets primary endpoint. As adjunctive treatment, a dose of 10 mg/kg/day (but not 2.5 mg/kg/day) resulted in statistically significant reduction in seizure frequency vs. placebo, the primary efficacy endpoint; data to be presented at later date [1].

Evidence based evaluations