The announcement comes after Veru — which also does business as Female Health Company — completed the first stage of a bioequivalence (BE) clinical trial to support the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) late this year or in early 2018. The BE study aims to show that DRS is similar in all its properties to Flomax. NDA approval is expected for the second half of 2018.
“Our results from Stage 1 of the BE trial demonstrated that Tamsulosin DRS may have an improved safety profile,” Veru President and CEO Mitchell Steiner, MD, said in a news release. “Unlike Flomax, Tamsulosin DRS is a slow-release powder that does not have to be administered after a meal and may be taken on an empty stomach. These benefits are especially important in the long-term care setting for men who have difficulty swallowing capsules or tablets and could also improve patient compliance.”
In Stage 2 of the BE clinical trial, researchers will compare the delivery of Tamsulosin DRS to Flomax in a large group of men with BPH. The medication is an extended-release powder formulation of the active ingredient in Flomax, a common oral treatment for BPH. Tamsulosin belongs to class of drugs alpha blockers, and works by relaxing bladder neck muscles and muscle fibers in the prostate itself, making it easier to urinate.
Tablets or capsules are problematic for 15 percent of men over the age of 60 with difficulties swallowing, and the up to 60 percent of men in long-term care facilities who have difficulty swallowing because of other medical conditions. Tamsulosin DRS is being developed for these men with BPH who have difficulty swallowing tablets or capsules.
“Today’s announcement further validates our product diversification strategy and recently completed merger transaction,” Steiner said. “Tamsulosin DRS should allow us to participate in the multibillion-dollar benign prostatic hyperplasia market and is just one of multiple drug candidates in our pharmaceutical pipeline that not only addresses large patient populations but also utilizes a potentially lower cost, lower risk and expedited approval pathway. We are making excellent progress with our entire drug portfolio and believe this is an important step in delivering significant value to our shareholders.”