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FDA Committee Recommends Uprima (Apomorphine) Sublingual Tablets For Erectile Dysfunction

LAKE FOREST, IL -- April 11, 2000 -- TAP Pharmaceutical Products, Inc. announced that the U.S. Food and Drug Administration's Urology Subcommittee of the Advisory Committee for Reproductive Health Drugs recommended approval for Uprima (R) (apomorphine HCl tablets) sublingual for the treatment of erectile dysfunction (ED). The committee's favorable recommendation will be considered by the FDA in its final review of the New Drug Application (NDA) for Uprima.

The committee suggested some cautionary recommendations for labeling. In addition, the committee advised that education materials be provided to patients at the point of care.

If approved, Uprima will be the first centrally acting oral ED treatment available to patients. "Uprima could offer several benefits for patients suffering from ED," says John Mulhall, M.D., director of the Center for Male Sexual Health at Loyola University Chicago and an investigator in the Uprima clinical trials. "In clinical trials, it worked quickly, in as fast as 10 minutes, with a median response time of 16-19 minutes. With its sublingual route of administration, it is not expected that Uprima will interact with food. Finally, data suggest that Uprima is safe and effective in men with varying severities of ED."

TAP submitted an NDA for Uprima on July 1, 1999, for 2 mg, 3 mg and 4 mg doses. The NDA was based on data from 27 clinical studies in 3,035 men.

"We are extremely encouraged by the recommendation, as we feel that Uprima would greatly enhance the therapeutic options of millions of men with ED. Further, Uprima will be a significant addition to our product portfolio, allowing us to further build on our experience in urology and primary care," says Thomas Watkins, president of TAP Pharmaceutical Products, Inc.

Erectile dysfunction is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual intercourse. Approximately 30 million American men suffer from some form of erectile dysfunction.

In clinical studies, Uprima was administered to men with organic, psychogenic, or mixed etiology erectile dysfunction, and was evaluated for its ability to produce an erection firm enough for intercourse. Initial studies with Uprima included patients with controlled hypertension and diabetes (type I and type II). TAP has also evaluated Uprima in patients following nerve-sparing radical prostatectomy.

In addition, a unique aspect of TAP's clinical studies was the assessment of patients' partners for satisfaction. This assessment showed corroboration of findings from the patient.

The most commonly reported side effect was nausea. Of the nausea reported in the NDA clinical studies, most incidences were mild to moderate in severity.

Apomorphine HCl tablets sublingual for male erectile dysfunction was licensed from Pentech Pharmaceuticals, Inc. of Buffalo Grove, Illinois.

TAP Pharmaceutical Products Inc. is a joint venture between Abbott Laboratories, headquartered in Abbott Park, Ill., and Takeda Chemical Industries, Ltd. of Osaka, Japan. Abbott and Takeda will jointly develop and co-market apomorphine in countries outside of the United States and Canada. TAP also markets Lupron Depot(R) (leuprolide acetate for depot suspension) for the palliative treatment of advanced prostate cancer, management of endometriosis, anemia caused by uterine fibroids in combination with iron, and central precocious puberty, and Prevacid(R) (lansoprazole) for the treatment of various acid-related disorders including gastroesophageal reflux disease (GERD) and ulcers. TAP has also submitted a NDA to the FDA for the cephalosporin antibiotic Spectracef(TM) (cefditoren pivoxil).

Related Link: TAP Pharmaceutical Products Inc.

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