New Lyrica formulation effective in trials
pharmafile | December 19, 2014 | News story | Sales and Marketing | HIV, Lyrica, Pfizer, pain, pregabalin, shingles
Pfizer has reported positive Phase III results for a new formulation of its painkiller Lyrica.
In the study, a controlled-release formulation of Lyrica (pregabalin) showed ‘statistically significant’ positive results for the treatment of postherpetic neuralgia (pain after shingles, or PHN).
This study is the final of three Phase III studies of controlled-release (CR) Lyrica that have been conducted to evaluate the potential use of the drug as a once-a-day therapy. A trial testing its efficacy in fibromyalgia – which causes pain all over the body – showed similarly positive results, but one in epileptic seizures failed to meet its primary endpoint.
In its statement Pfizer adds that the CR formulation was well-tolerated and that its safety profile is consistent with the profile for standard Lyrica. The most common adverse events with CR Lyrica were dizziness, somnolence, peripheral edema and weight increase.
PHN is a type of peripheral neuropathic pain caused by nerve damage. Its symptoms include continued burning or electric shock-like pain.
The standard formulation of Lyrica is currently approved for various indications across the world, including PHN, epilepsy, and neuropathic pain associated with diabetes and spinal cord injury. It was Pfizer’s top selling drug last year and has continued to see increasing revenue in 2014, which has led to the US giant relying on it more and more as top drugs like Lipitor (atorvastatin) go off-patent.
However, a small study by the University of Rochester in the US recently found that the medicine is no better than a placebo in reliving symptoms of severe lumbar spinal stenosis – the most common cause of back pain. Although Lyrica is not approved by the FDA for spinal stenosis, it is frequently prescribed off-label for this indication.
In 2012 Pfizer also tested Lyrica for the treatment of nerve pain in HIV and diabetes patients, but Phase III trials failed to show any benefits to using the drug.
George Underwood
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