Elestrin (estradiol gel 0.06%) was approved for this application by the FDA in December 2006. Bradley in-licensed Elestrin, which is patent protected until 2022, from BioSante Pharmaceuticals in late 2006, and has exclusive marketing rights for the treatment in the US.
In order to support the launch of Elestrin to the OB/GYN specialty market, Bradley said that it will immediately increase Kenwood's sales representatives. There are approximately 14,000 OB/GYN physicians in the US who account for the majority of prescriptions in the $1.3 billion US estrogen therapy market, the company said.
“After the Women's Health Initiative study in July 2002 detailed potential health risks associated with estrogen therapy, women have been seeking new alternatives,” stated John Knoop, vice president and general manager of Bradley's Kenwood Therapeutics division.
Elestrin is a fast-drying gel that is applied once-daily and delivers a consistent supply of estrogen to the bloodstream over 24-hours. In clinical trials patients experienced no endometrial hyperplasia during the twelve week study, Bradley revealed.
“Elestrin will provide physicians with an important treatment option for patients who choose to manage their hot flashes. We are confident that Elestrin will make a significant contribution to women's healthcare and look forward to working with key OB/GYN physicians to make Elestrin a success,” said Daniel Glassman, president and CEO of Bradley Pharmaceuticals.
Bradley said that the most frequently reported adverse events in clinical trials of Elestrin were nasopharyngitis, breast tenderness, upper respiratory tract infection, and metrorrhagia.