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BY OUR PHARMA CORRESPONDENT
11 August, 2005: A New Drug Application (NDA) has been filed by Pozen Inc with the US FDA seeking marketing approval for the combination of sumatriptan succinate, formulated with RT Technology, and naproxen sodium, in a single tablet. The combo, to be named Trexima, is indicated for the treatment of acute migraine.
Trexima submission is ahead of schedule and within four months from the database lock on the last pivotal clinical study for the NDA. This has been collaborative efforts put forth by team members from both GlaxoSmithKline (GSK) and Pozen, said a Pozen release.
Upon the FDA's acceptance for filing of the Trexima NDA, a $20 million milestone payment from GSK is payable to Pozen.
There are an estimated 25 to 30 million migraine sufferers in the U.S. alone. Only half of U.S. migraine sufferers are currently diagnosed by physicians and only two-thirds of these diagnosed patients use prescription medications. Some of the current therapeutic alternatives lack efficacy or produce undesirable side effects. Over-the-counter medicines are generally the first step for many migraine patients, however, they are unable to provide the sustained pain relief associated with prescription medicines.
Today, most of the multi-billion dollar worldwide prescription market is represented by triptans. Although this class of drug represents a major breakthrough in migraine care, fewer than 40% of triptan patients consistently get 24-hour pain relief. Also, triptan use is not recommended in patients with known cardiovascular risk factors.
Pozen is a pharmaceutical company developing therapeutic advancements for diseases with unmet medical needs. Currently developing products for migraine therapy, a multi-billion dollar global market. Pozen has three product candidates, each designed with a unique profile to treat different stages of migraine attacks - mild, moderate and severe.
Pozen has development and commercialization alliances with GlaxoSmithKline, Valeant Pharmaceuticals North America, a subsidiary of Valeant Pharmaceuticals International (formerly Xcel Pharmaceuticals, Inc.), and Nycomed Danmark ApS.
BY OUR PHARMA CORRESPONDENT
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