In the pipeline

Drugs in Development and New Indications

Migraine Relief

Pozen, Inc, announced that it plans to submit a full response to the US Food and Drug Administration’s (FDA) approvable letter for its oral single-tablet combination of GlaxoSmithKline’s triptan, sumatriptan succinate, and the nonsteroidal anti-inflammatory drug (NSAID) naproxen sodium for the acute treatment of migraine. After two phase 3 pivotal trials designed to determine the effec- tiveness and safety of the the triptan/NSAID combination (Trexima), the FDA issued an approvable letter with a request for more information on the safety and efficacy of the drug. In clinical trials, the drug proved to be more efficacious than use of triptans or NSAIDs alone.

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Detecting Human Papillomavirus

Third Wave Technologies, Inc, is preparing for clinical trials of two new human papillomavirus (HPV) test products. The company plans to submit two new applications to the FDA for a screening test that will detect 14 types of high-risk HPV infection in addition to a geno-typing test that is capable of detecting HPV types 16 and 18; these two types are the cause of approximately 70% of cervical cancer cases.

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Easing Emesis

Abeille Pharmaceuticals, Inc, recently submitted a special protocol assessment of its phase 3 pivotal efficacy study protocol for review by the FDA for its novel AB-1001 transdermal patch for the relief of chemotherapy-induced nausea and vomiting. The patch is designed to deliver a continuous dose of a commercially available 5–HT3-antagonist for up to 5 days of continuous symptom relief from emeto-genic chemotherapy.

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