Pregabalin
ArticlesMedicine Compliance Aid StabilityLactation Safety InformationNew Medicines · Published , updated
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Articles
21 September 2020
Safety in Lactation: Control of epilepsy
Choice will depend on clinical condition, and should primarily be based on suitability for the patient, rather than safety during breastfeeding. Whilst sodium valproate is… Carbamazepine Clobazam Clonazepam Ethosuximide Gabapentin Lacosamide Lamotrigine Levetiracetam Oxcarbazepine Perampanel Phenobarbital Phenytoin Pregabalin Primidone Sodium valproate Topiramate Zonisamide
10 January 2020
What non-hormonal alternatives to antidepressants are available for the management of menopausal hot flushes?
This is one of two UKMi Medicines Q&As addressing the management of menopausal hot flushes (vasomotor symptoms) with non-hormonal drug therapy. Clonidine Gabapentin Methyldopa Obstetrics and gynaecology Octreotide Oxybutynin Pregabalin Sulpiride
16 April 2018
Gabapentin and pregabalin—are they safe whilst breastfeeding?
This UKMi Medicines Q & A reviews the evidence available, and makes recommendations, for the use of gabapentin and pregabalin during breastfeeding. Summary: Limited data… Gabapentin Obstetrics and gynaecology Paediatrics and neonates Pregabalin Safety in Breastfeeding
30 August 2017
How do you switch between pregabalin and gabapentin for neuropathic pain, and vice versa?
This recently updated Medicines Q&A evaluates the limited published evidence available on managing a switch between pregabalin and gabapentin for neuropathic pain, and vice versa. Anaesthesia and pain Gabapentin Pregabalin Switching
3 July 2013
Gabapentin and Pregabalin Offender Health Audit Report and Audit Tool
This report and associated survey and audit tool describe the process and outcomes of an England-wide collaborative audit and survey of the use of gabapentin… Gabapentin Health and Justice Pregabalin Research and auditsMedicine Compliance Aid Stability
Lyrica
Pfizer Ltd
Pfizer Ltd
Lyrica
Capsules 25mg, 50mg, 75mg, 100mg, 150mg, 225mg, 300mg,
A2 · Amber 2 No 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
Lyrica
Partial onset seizures in children - adjunctive therapyInformation
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 20
Lyrica 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 20
EU 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 19
The 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 16
PIII 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 19
PIII 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 19
PIII 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 19
Pfizer 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 18
Pfizer 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 18
Pfizer completes a PIII trial in partial epilepsies, adjunctive treatment, in infants & children (NCT02072824) [3].
Dec 16
Pfizer 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].