Pfizer’s Lyrica fails at Phase 3 in treating primary generalised tonic-clonic (PGTC) seizures

pharmafile | May 28, 2019 | News story | Manufacturing and Production, Research and Development, Sales and Marketing Lyrica, Pfizer, epilepsy, pharma, trial failure 

Pfizer has unveiled new Phase 3 data on the effectiveness of Lyrica (pregabalin) in the adjunctive treatment of primary generalised tonic-clonic (PGTC) seizures in patients between the ages of five and 65 years old, revealing that the therapy failed to meet its primary endpoint.

Specifically, Pfizer announced that use of the drug did not lead to a statistically significant reduction in seizure frequency compared to placebo in testing of 219 participants. However, the manufacturer did note that the drug’s safety profile was consistent with previous findings.

“Pfizer is committed to the study of patient populations with unmet treatment needs, including pediatric and adult patients experiencing generalised tonic-clonic seizures,” commented Dr Juan Ovalle, Global Chief Medical Officer, R&D and Medical at Upjohn, a division of Pfizer. “These data contribute to our growing understanding of paediatric epilepsy and reflect our responsibility to advance scientific knowledge through post-marketing research.”

The announcement seriously impacts Lyrica on its path to securing approval in the indication; the therapy is so far not indicated in any form as treatment for PGTC seizures.

Matt Fellows

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