Pfizer’s Lyrica has failed to meet its primary endpoint in a Phase III study for a new pain-related indication.
The company said that the drug did not reduce pain compared to a placebo in patients suffering from chronic post-traumatic peripheral neuropathic pain – nerve pain caused by traumatic accidents or surgeries – for which there are currently no approved treatments.
Lyrica (pregabalin) is already approved to treat nerve pain associated with diabetes, shingles, spinal cord injury and fibromyalgia in adults, as well as epilepsy.
In March the drug failed to hit its primary endpoint in a post-marketing study in 12-17 year olds with fibromyalgia.
Last year it also became the centre of a court case after its patent protection for epilepsy expired and Actavis launched a generic version. Pfizer argued that the generic would inevitably be used to treat pain and therefore infringe on its second-use patent for this indication – but the High Court of England and Wales ruled that Pfizer’s patent protection for Lyrica in the UK is invalid and not infringed by Actavis’ copycat drug.