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.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
At DeviceTalks Boston, MacMillan will provide exclusive insights into the Massachusetts-based company and its evolving definition of women's healthcare. You don't want to miss it!
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