Mallinckrodt Pharmaceuticals (NYSE:MNK) said today that the FDA granted orphan drug status to its long-acting cosyntropin acetate formulation, MNK-1411, for the treatment of Duchenne muscular dystrophy.
In August last year, the FDA approved the company’s request to fast track its investigational new drug application for the therapy.
“We are pleased the FDA has granted orphan drug status to MNK-1411 for potential treatment of DMD, a serious disease for which there are limited treatment options,” exec VP & chief scientific officer Dr. Steven Romano said in prepared remarks. “Mallinckrodt believes MNK-1411 may have potential to offer physicians and patients a new treatment alternative, and this designation is an important step forward for the development program. We continue to advance our broad clinical and regulatory strategy in areas of high unmet medical need.”
Mallinckrodt has finished a Phase I study of MNK-1411 in healthy volunteers and is slated to launch a Phase II trial later this year to determine optimal dosing for patients with DMD.
Also this week, Mallinckrodt agreed to pay $35 million to settle claims that it failed to report suspicious orders for addictive opioids.
The company’s general counsel, Michael-Bryant Hicks, told Reuters that the company chose to settle in an effort to “eliminate the uncertainty, distraction and expense of litigation and to allow the company to focus on meeting the important needs of its patients and customers.”