In the pipeline

Drugs in Development and New Indications

Osteoarthritis Pain Reduction

After a 12-week phase 3, five-arm, double-blind, placebo-controlled trial of 775 patients in the United States and Canada, Nuvo Research, Inc, announced resubmission of its new drug application to the US Food and Drug Administration (FDA) for its topical nonsteroidal anti-inflammatory drug (Pennsaid). The topical application is indicated for the treatment of primary osteoarthritis of the knee. The clinical trial met all of the primary endpoints including pain reduction, improvement of physical function, and improved overall health assessment, and demonstrated comparable efficacy to oral diclofenac.

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Alleviating Anal Fissure Pain

The FDA issued an approvable letter to Cellegy Pharmaceuticals, Inc, for its nitroglycerin ointment, 0.4%, for the treatment of pain associated with chronic anal fissures (Cellegesic). The FDA stated that the product may be approved, but requested an additional clinical trial to determine whether the treatment demonstrates a statistically significant level of efficacy. Currently, there are no FDA-approved treatments for anal fissure. Cellegy hopes to address this unmet need with an FDA-approved standardized formula rather than the unregulated custom nitroglycerin compounds that are currently hand-made by pharmacies to treat the disorder.

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Postponing Puberty

A new drug application has been submitted to the FDA by Valera Pharmaceuticals, Inc, for a 12-month implant for central precocious puberty (Supprelin-LA). Unlike currently available leuprolide acetate for depot suspension injections, which are administered every 4 weeks, the implant is designed to deliver a continuous, controlled dose of the gonadotropin-releasing hormone (GnRH) agonist histrelin over a 1-year period. In a multi-center, open-label, phase 3 trial, the implant was analyzed for safety and efficacy in 36 patients aged 4 to 11 years, with endpoints of suppressing hormone production below pubertal level, and continued suppression when challenged with GnRH.

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A Year of Pregnancy Prevention

Wyeth received an approvable letter from the FDA for its 90-mcg levonorgestrel (LNG)/20 mcg ethinyl estradiol (EE), low-dose, continuous, noncyclic combination oral contraceptive (COC) for the prevention of pregnancy (Lybrel). The LNG/EE adjuvant used in COCs has been well-studied, but Wyeth's investigational drug is the first to utilize this combination in a 365-day, placebo- or pill-free regimen.

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Building Bone Mineral Density

Amgen released findings from a year-long clinical trial of twice-yearly injections of denosumab for the treatment of osteoporo-sis. In the trial, 412 healthy postmenopausal women were randomized to receive injections of denosumab, placebo, or alendronate (Fosamax). The study showed denosumab significantly increased bone mineral density (BMD) at the hip from 1.9% to 3.6% in women who were administered the drug twice yearly, compared to a BMD decrease of 0.6% with placebo at 1 year. There were similar results for BMD increase at the lumbar spine (3.0% to 6.7%), distal 1/3 radius (0.4% to 1.3%), and total body (0.6% to 2.8%) compared to BMD loss with placebo (0.8%, 2.0%, 0.8%, respectively) (P < .001).

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