Aspen Park Pharmaceuticals (APP) announced that the U.S. Food and Drug Administration (FDA) has agreed to an expedited regulatory review process for Tamsulosin DRS, the pharmaceutical’s lead powder formulation of the widely used alpha-blocker Flomax (tamsulosin), as a potential treatment for benign prostatic hyperplasia (BPH).
“FDA’s decision to allow us to utilize its 505(b)(2) regulatory pathway is a significant milestone for the accelerated development of our BPH product,” Mitchell Steiner, APP’s president and chief executive officer, said in a press release. “The U.S. market for Flomax and its generic equivalents which are currently only available in tablet or capsule form is about a $3.5 billion market.”
Th next step is conducting a bioequivalence study to support the filing of a New Drug Application (NDA) with the FDA, and the company plans to begin a three-week study late this year. If successful, it will submit an NDA requesting the approval of Tamsulosin DRS early next year.
Earlier this year, Aspen Park merged with the Female Health Company (FCHO), best known for the female condom. The merger is expected to result in the creation of a new company, called Veru Healthcare and led by Steiner.
Most products in the new company will focus on men’s health, including prostate cancer-related hot flashes, gout, and male infertility.
Tamsulosin DRS is a new and extended-release powder formulation of the active ingredient in Flomax, a common oral treatment for BPH available that has been available in approved generic forms since 2010. Tablets or capsules are problematic for 15% of men over the age of 60 with difficulties swallowing, and the up to 60% of men in long-term care facilities who have difficulty swallowing because of other medical conditions, according to another press release.