Pfizer’s Lyrica fails phase 3 trial in epilepsy
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.
“Pfizer is committed to the study of patient populations with unmet treatment needs, including pediatric and adult patients experiencing generalized tonic-clonic seizures,” said Juan Ovalle, M.D., Global Chief Medical Officer, R&D and Medical, Upjohn, a division of Pfizer. “These data contribute to our growing understanding of pediatric epilepsy and reflect our responsibility to advance scientific knowledge through post-marketing research.”
Lyrica is one of Pfizer’s leading drugs, but is facing headwinds as it loses exclusivity outside the US. In the first quarter of 2019, sales dropped 2.2% to $1.2 billion.
In the UK the drug has been at the centre of a legal battle over a second-use patent for the drug in neuropathic pain – a battle it eventually lost, opening it up for even more generic competition in the country.
Meanwhile, in the US Lyrica was one of several Pfizer drugs to see a price rise last year, leading the company to incur the ire of president Trump and a public that is increasingly frustrated with pharmaceutical pricing.