Mylan has acquired global development and marketing rights from Prayog Labs to bring to market a fast-acting Meloxicam as a proposed non-narcotic analgesic. This novel delivery has the potential to provide a non-addictive treatment option for acute pain that patients may experience, for example, during dentistry procedures, post-surgery and with orthopedic defects. Meloxicam also is proposed to treat chronic pain.
"We recognize the severity of the opioid crisis as a nationwide public health issue and are committed to doing our part to help in the fight against opioid addiction, abuse and misuse. Offering an alternate, non-opioid pain treatment option represents at least a step toward addressing this national health crisis,” Mylan CEO Heather Bresch said. “Over the course of our almost 60-year history, we have leveraged our expansive scientific capabilities on multiple occasions to help address some of the world's toughest public health issues. We look forward to bringing a novel delivery form of Meloxicam to market for healthcare providers, patients and the public at-large who are affected by this epidemic."
Prayog Labs has completed the initial active pharmaceutical ingredient and formulation development, as well as a pharmacodynamic and preclinical evaluation. Mylan will be submitting an investigational new drug application to the FDA and plans to use the 505(b)(2) regulatory pathway for product approval.