FDA Approves Two New Products for Chronic Pain

The FDA recently approved Pfizer's Lyrica™ (pregabalin capsules) for the management of neuropathic pain and Prialt™ (ziconotide intrathecal infustion) for severe chronic pain.

Lyrica

Lyrica was developed to manage neuropathic pain associated with diabetic neuropathy (DPN) and postherpetic neuralgia (PHN), a complication of shingles. Lyrica's efficacy was established in six double-blind, placebo-controlled trials. It provided rapid and clinically meaningful pain reduction in a significant portion of patients, with pain relief beginning as early as the first week of treatment in some patients and was sustained in studies of up to 12-weeks long. The most common side effects were dizziness, somnolence, dry mouth, peripheral edema, blurred vision, weight gain, and difficulty with concentration/attention.

Lyrica, expected to be classified as a controlled substance, will probably be available in mid-2005.

Prialt

The FDA approved Prialt, a non-narcotic drug for the managementof severe chronic pain in patients for whom intrathecal (IT) therapy is warranted and who are intolerant of, or refractory to other treatment, such as systemic analgesics, adjunctivie therapies or IT morphine. The FDA approval of Prialt was based on the treatment of more than 1,200 people and the results of three Phase III clinical trials. The trials evaluated the efficacy and safety of IT Prialt in patients with severe chronic pain that was inadequately managed with other treatments. Prialt is approed for use only in the Medtronic SynchroMed® EL, SynchroMed® II Infusion System, and Simms Deltec Cadd Micro® External Microinfustion Device and Catheter.

Prialt is in a class of non-opoiod analgesics known as N-type calcium channel blockers. It is the synthetic equivalent of a naturally occurring conopeptide found in a marine snail known as conus magus. Research suggests that Prialts mechanism of action works by targeting and clocking N-type calciium channels on nerves that ordinarily transmit pain signals.

Prialt is expected to be available to physicians and patients in the US in late January.

January 18, 2005