Pfizer has reported top-line results from two Phase IIIb, placebo-controlled trials with Lyrica (pregabalin) capsules CV in patients with fibromyalgia (FM) and painful diabetic peripheral neuropathy (DPN) respectively.
In addition to meeting the primary endpoint, the multicentre, double-blind, randomised, placebo-controlled, two-way cross-over study of Lyrica showed reduction in fibromyalgia pain in patients who were treated concurrently with antidepressant therapy for co-morbid depression.
The company said the painful DPN study did not meet its co-primary endpoints by reducing DPN pain and DPN pain on walking compared twithplacebo.
Some 197 patients diagnosed with both fibromyalgia and comorbid depression were enrolled in the fibromyalgia study who were taking a stable dose of a single antidepressant medicine for their depression for at least three months before the study.
In each of the two double-blind treatment periods, patients were given Lyrica 300mg/450 mg or placebo twice per day during a six-week treatment phase, followed by a two-week washout period, and later crossed over to the opposite treatment for more six weeks.
The results from the fibromyalgia study show consistency in Lyrica’s safety profile when compared with previous studies and current product labelling.
A total of 205 patients enrolled in the multicentre, double-blind, placebo-controlled cross-over efficacy and safety DPN study were randomised to receive Lyrica 150mg/300mg or placebo per day.
Co-primary endpoints of the study were DPN pain evaluated by diary-based, daily pain scores and pain on walking assessed after walking 50ft on a flat surface.
According to the company, painful DPN and pain on walking were reduced in patients treated with Lyrica or placebo but the study did not show a significant difference between Lyrica and placebo in the co-primary endpoints.
Lyrica is currently used for several indications in 120 countries and regions worldwide.
The drug has been approved for five indications in the US, with four in the therapeutic area of pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, neuropathic pain associated with spinal cord injury, fibromyalgia and partial onset seizures in adults with epilepsy.
In the EU, the drug is approved for peripheral and central neuropathic pain, generalized anxiety disorder in adults, and partial seizures with or without secondary generalisation in adults with epilepsy.
The company said, Lyrica is the only treatment approved in Japan for all three of the following indications including post-herpetic neuralgia, neuropathic pain and pain associated with FM.