Mylan has acquired global development and marketing rights from Prayog Labs LLC 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.
In October 2017, the U.S. Department of Health and Human Services declared a nationwide public health emergency regarding the opioid crisis, serving as a rallying cry for affected families, communities, advocacy groups, healthcare professionals, policymakers, and the entire healthcare industry to come together to address a serious epidemic debilitating the country.
While Mylan is not a major manufacturer of opioid products, the company is is interested in being a part of the long-term solution. Promoting the development of non-opioid pain treatments is one of the many tactics the FDA is focused on as part of its efforts to address this growing public health problem.
Mylan CEO, Heather Bresch, commented, “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.”
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.
Mylan President, Rajiv Malik, added, “At Mylan, part of being built to last is finding the right technologies that can advance our mission to deliver better health for a better world. This novel delivery form of Meloxicam is particularly significant because it could play an important role in addressing a public health crisis. Adding a fast-acting Meloxicam to our pipeline is meaningful not because it will be a key growth driver, but because it’s the right thing to do.”
(Source: Mylan N.V.)
Filed Under: Drug Discovery