P&G May Choose Intrinsa, Nuvessa Or Adveon To Name Testosterone Patch
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Procter & Gamble may be considering the tradenames Intrinsa, Entrinsa, Intrensa, Nuvessa, and Adveon for its testosterone replacement patch therapy for female sexual dysfunction. The firm submitted the names to the Patent and Trademark Office for a transdermal hormone replacement patch.
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Procter & Gamble may be considering the tradenames Intrinsa , Entrinsa , Intrensa , Nuvessa , and Adveon for its testosterone replacement patch therapy for female sexual dysfunction. The firm submitted the names to the Patent and Trademark Office for a transdermal hormone replacement patch. P&G has marketing rights to the transdermal patch and is collaborating with Watson Labs on its development. A Phase II study has been completed, and Phase III trials are slated to begin in the first quarter of 2002. In Phase II studies in surgically menopausal women, subjects in the three treatment groups (300 microgram and 150 microgram daily testosterone vs. placebo) reported increased sexual activity and pleasure, but "significantly greater improvement" was seen in the 300 microgram dose group compared to placebo, the company reported. California-based Protein Design Labs may choose from the names Tactent , Prenity , Brezant and Prensior for several of its products in development. The firm submitted these names to the PTO for an agent to treat autoimmune, inflammatory and allergic diseases and oncologic or hematologic malignancies. Previously, the firm submitted potential tradenames Restogen , Zamil and Zamyl . PDL may be considering the names for its humanized anti-IL-4 monoclonal antibody in Phase II for asthma. The placebo-controlled trial is evaluating use of the monoclonal antibody in 120 symptomatic asthma patients who are not on controller medications (including steroids, leukotriene modifiers, or long-acting beta agonists). The agent is being developed in collaboration with GlaxoSmithKline. PDL's SMART anti-gamma interferon antibody, in Phase I/II trials for moderate to severe Crohn's disease, also may be a candidate for one of the tradenames. Data from the antibody study will be presented at Digestive Diseases Week in San Francisco May 19-22. Phase II trials are expected to begin in the first half of 2002. Albuleukin-2 and Albuleukin may be tradename choices for Human Genome Sciences' albumin-fusion product albumin-interleukin-2, in preclinical development. The company submitted the names to the PTO for a fusion protein product to treat cancer. The agent was originally developed by Principia, which was acquired by HGS. HGS has two albumin-fusion therapies in clinical trials. Albuferon , an albumin-fusion version of human interferon alpha, is in Phase I trials for treatment of hepatitis C. Albutropin , a fusion of human growth hormone and albumin, is in Phase I study for treatment of growth-hormone deficiency. |