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FDA action date is set for long-acting hypogonadism Rx

Indevus Pharmaceuticals, Inc.'s complete response submission to the new drug application for testosterone undecanoate (NEBIDO) intramuscular injection, an investigational testosterone preparation, has been accepted for review by the FDA. Sept. 2, 2009 is the targeted action date for a decision on this application. The drug is a long-acting, injectable testosterone preparation for the treatment of hypogonadism.

Phase III study to commence for premature ejaculation agent

PSD502 is a propietary formulation of lidocaine and prilocaine that is dispensed by a metered dose aerosol. Preliminary results from this study, conducted in North America, are expected in mid-year 2009.

All patients for the study have entered a 4-week screening and baseline period. At least 240 patients are expected to be randomized to a 12-week, double-blind treatment period, followed by an optional open-label phase.

Erectile dysfunction drug enters second phase III study

VIVUS, Inc. has initiated a second phase III study of avanfil, an investigational phosphodiesterase type-5 inhibitor for the treatment of erectile dysfunction. The study, REVIVE-Diabetes (TA-302) is a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of avanafil in the treatment of ED in men with type 1 or type 2 diabetes.

Prostate cancer agent to enter phase III trial after FDA agreement

Cougar Biotechnology, Inc. has reached agreement with the FDA under a special protocol assessment (SPA) for its planned phase III clinical trial of CB7630 (abiraterone acetate) in patients with chemotherapy-naïve, castration-resistant prostate cancer. The SPA is a written agreement between the company and the FDA regarding the design, endpoints, and planned statistical analysis approach of the trial.

The trial will be a randomized, double-blind, placebo-controlled trial of abiraterone plus prednisone in patients who have not yet received chemotherapy.

Positive results from ongoing phase II clinical trials of abiraterone were recently presented at the Genitourinary Cancers Symposium in Orlando, FL, Cougar Biotechnology reported.

PSA-activated BPH treatment moves into phase II study

Protox Therapeutics Inc. has initiated a double-blind, placebo-controlled phase II study of PRX302 in patients with BPH. PRX302 was generated by engineering the toxin proaerolysin so that it is activated by PSA.

Safety board recommends continuation of PCa drug study

An independent data safety monitoring board has recommended that GTx, Inc. continue its planned phase III trial of toremifene, 20 mg, for the prevention of prostate cancer in men with high-grade prostatic intraepithelial neoplasia.

The trial is being conducted under a special protocol assessment between the company and the FDA.