Phase III trial of Lyrica (pregabalin) fails to meet endpoint in peripheral neuropathic pain- Pfizer

Pfizer has announced top-line results of a Phase III study evaluating the efficacy and safety of Lyrica (pregabalin) Capsules CV in adults with chronic post-traumatic peripheral neuropathic pain. The study did not meet its primary efficacy endpoint.

The study was conducted as a 15-week, double-blind, placebo-controlled, parallel group study with a primary objective to evaluate the efficacy of pregabalin in the treatment of chronic post-traumatic peripheral neuropathic pain. The primary efficacy endpoint was mean pain reduction from baseline compared with placebo based on pain scores from patients� daily pain diaries. The safety profile observed in this study was consistent with that known for pregabalin. The most common adverse events with pregabalin in this study were dizziness, somnolence, nausea and fatigue. There is currently no treatment approved by the FDA for post-traumatic neuropathic pain.

Comment: In April 2015, a UK High Court ruling stated that the NHS should not promote generic pregabalin in instances of pain, although it can be used to treat epilepsy and generalised anxiety disorder, which are not covered by Pfizer�s expired patent. As a result, NHS England issued guidance to GPs and pharmacists on 27 February saying that, �so far as reasonably possible�, GPs should stipulate Lyrica when prescribing pregabalin for pain and those dispensing the drug should give out the branded version. Generics companies--including Actavis --have challenged the 2017 patent, with a trial set. Teva has its own Lyrica patent fight ongoing. If the English court orders Pfizer's patent to be revoked, then the generics can proceed. Pfizer is likely to appeal and the case could keep that 2017 patent in abeyance for some time--perhaps even until 2017.