US drugmaker Pfizer has reported results from its Phase III trial of Lyrica (pregabalin) Capsules CV in adults with chronic post-traumatic peripheral neuropathic pain.
The trial failed to meet the primary efficacy endpoint, which was an overall pain reduction compared with placebo results.
The pain reduction was measured using pain scores from patient diaries.
The 15-week trial was designed to evaluate the efficacy and safety of pregabalin in the treatment of chronic post-traumatic peripheral neuropathic pain.
The company noted that the trial’s safety profile was consistent with that known for pregabalin, and the most common symptoms were dizziness, somnolence, nausea and fatigue.
There is currently no treatment for post-traumatic neuropathic pain approved by the US Food and Drug Administration (FDA).
In the US, Lyrica is approved to treat pain from damaged nerves caused by diabetes, shingles, spinal cord injuries, fibromyalgia, and certain types of epileptic seizures.
Earlier this week, Pfizer agreed to buy Irish Botox maker Allergan for $160bn, making it the world’s largest pharmaceutical company.
Pfizer’s shareholders will receive 11.3 shares of the new firm for each of their existing shares.
Pfizer stockholders will receive one share of the new company for each of their shares, or a cash payment from $6bn to $12bn.
As part of the proposed deal, the businesses of both companies will be combined under Allergan, which will be renamed as Pfizer.
Image: Pfizer world headquarters. Photo: courtesy of Jim.henderson.