Pfizer’s Lyrica has failed to meet its primary endpoint in a phase 3 trial in primary generalised tonic-clonic (PGTC) seizures. The study evaluated two doses of the drug – 5 mg and 10 mg – over a period of 12 weeks.
Treatment with the drug did not result in a statistically significant reduction in seizure frequency versus placebo.
The safety profile was similar to that observed in other studies.
The trial was conducted as a post-marketing requirement by the FDA.
Pfizer is investigating the drug as part of its wider Lyrica Pediatric Epilepsy Program, which is composed of six studies in patients with epilepsy evaluating Lyrica as adjunctive therapy, five of which have been completed.
Another phase 3 trial in May 2018 was successful, showing that in paediatric patients with epilepsy a 14 mg dose of Lyrica resulted in a statistically significant reduction in seizure frequency versus placebo – however no statistically significant reduction was observed with a 7 mg dose.