Pfizer's (PFE) Epilepsy Drug Lyrica Fails in Phase III Study

Pfizer Inc. PFE announced that its epilepsy drug, Lyrica (pregabalin), failed to meet primary endpoint in a phase III study, evaluating it as adjunctive therapy in  epilepsy patients (aged 5 to 65 years) with primary generalized tonic-clonic (“PGTC”) seizures.

Data from the study showed that treatment with Lyrica was not able to achieve a statistically significant reduction in seizure frequency versus placebo in the PGTC seizure patient population.

In the United States, Lyrica is approved for fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles.

Notably, the study was a post-marketing requirement by the FDA. Lyrica is not approved as adjunctive therapy for PGTC seizures in any patient population.

The phase III study evaluated two doses of Lyrica – 5 mg/kg/day and 10 mg/kg/day – over a period of 12 weeks. The safety profile of the drug was similar to observed in earlier clinical studies.

Year to date, shares of Pfizer have lost 3.9% against the industry’s 0.7% increase.

Pfizer is developing Lyrica as adjunctive therapy in a pediatric epilepsy program including six studies. The company has completed five studies in the program.

We remind investors that, in May 2018, Lyrica successfully completed a phase III study on pediatric patients with epilepsy. Top-line results from the study showed that adjunctive treatment with Lyrica 14 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo, which was the primary efficacy endpoint. However, the treatment with Lyrica at lower dose of 7 mg did not result in statistically significant reduction in seizure frequency versus placebo.

Based on this data along with data from other studies from the pediatric epilepsy program, the drug was granted pediatric exclusivity in November 2018. Following the approval, Lyrica’s exclusivity was extended by six months to Jun 30, 2019. The drug is set to face generic competition in the U.S. markets, following the loss of exclusivity in June end.

We note that Lyrica is one of the leading brands in Pfizer’s marketed drug portfolio. In the first quarter of 2019, global sales of the drug declined 2.2% to $1.2 billion, mainly due to lower sales in the regions outside the United States, where it has lost exclusivity.

At present, several companies are developing their candidates targeting several forms of epilepsy in pediatric as well as adult patients. These include Zogenix, Inc.’s ZGNX ZX008, Insys Therapeutics, Inc.’s INSY cannabidiol oral solution and Marinus Pharmaceuticals, Inc.’s MRNS ganaxolone among others.

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