The pharma giant is positioning the medication, Meloxicam, as a non-addictive treatment option for patients experiencing acute pain following dentistry procedures or following a surgery.
Prayog Labs has finished initial development work on the product’s formulation, Mylan said, and has conducted pre-clinical studies. Mylan is slated to submit an investigational new drug application t0 the FDA, following a 505(b)(2) pathway.
“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. 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,” CEO Heather Bresch said in prepared remarks.
“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,” president Rajiv Malik added.