FREDERICK, MD, Nov. 27, 2018 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — BioElectronics Corporation (OTC Pink: BIEL), the maker of non-invasive electroceutical devices, announced that the U.S. Food & Drug Administration (FDA) declined the company’s 510(k) submission for ActiPatch®, intended for seeking expanded over-the-counter (OTC) indications for the treatment of musculoskeletal pain. In the back pain study that was submitted to the FDA as clinical evidence, the ActiPatch was found to have a significant treatment effect in women, but only a mild treatment effect in men. Since gender differences in treatment effects were not identified in prior ActiPatch clinical studies (knee and plantar fasciitis pain), the FDA concluded that the clinical evidence in the current 510(k) application was “not substantially equivalent” to the prior evidence.
The medical community acknowledges that there are gender differences in responses to pain therapies , and importantly, that women experience pain more intensely than men . Moreover, women are at a greater risk of using opioids than men to combat chronic pain . Given the risks inherent with opioid use, as well as limited efficacy of other pharmacotherapy options such as NSAID’s and topicals, there is a dire need for a safe and effective non-pharmacological pain therapy like ActiPatch. Gender-level analysis of the prior ActiPatch clinical data revealed that there indeed were differences in treatment effects between men and women, with women reporting more pain relief than men. The company intends to leverage these findings and resubmit the 510(k) application for a more specific indication: relief of musculoskeletal pain for women. Our sales data are compatible with the observation that women get substantial relief in that about 70% of our sales are to women.
Sree Koneru, VP of Product Development, expressed confidence in this strategy, both from a regulatory and marketability perspective. “We are also diligently proceeding with 510(k) applications for US market clearance of postoperative pain (RecoveryRx®) and menstrual pain (Allay®),” he added.