Pfizer Inc announced top-line results from a double-blind Phase 3 study evaluating pregabalin controlled-release (CR) formulation in adult patients with postherpetic neuralgia (pain after shingles or PHN). The results show that pregabalin CR resulted in a statistically significant positive effect compared to placebo in the primary endpoint, time to loss of therapeutic response (LTR) in pain reduction. PHN is a type of peripheral neuropathic pain caused by nerve damage. Symptoms include continued burning or electric shock-like pain.
This study is the final of three Phase 3 studies of the pregabalin CR formulation conducted to ascertain the potential use of pregabalin as a once-a-day therapy. The first study in adults with partial onset seizures with epilepsy did not meet its primary endpoint. In the second study in patients with fibromyalgia, pregabalin CR had a statistically significant positive effect compared to placebo in the primary endpoint, time to LTR in pain reduction.
Lyrica® is currently approved for various indications in 120 countries and regions globally. Lyrica is approved for five indications in the U.S., of which four are in the therapeutic area of pain. These indications include neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia (pain after shingles), neuropathic pain associated with spinal cord injury, fibromyalgia and partial onset seizures in adults with epilepsy who take one or more drugs for seizures.
Lyrica’s ongoing clinical development program is focused on the significant unmet needs of patients with certain chronic pain conditions. Antiepileptic drugs (AEDs), including Lyrica, increase the risk of suicidal thoughts or behavior in patients taking AEDs for any indication. There have been post-marketing reports of angioedema and hypersensitivity with Lyrica. Treatment with Lyrica may cause dizziness, somnolence, dry mouth, edema and blurred vision. Other most common adverse reactions include weight gain, constipation, euphoric mood, balance disorder, increased appetite and thinking abnormal (primarily difficulty with concentration/attention).
