Questcor Pharmaceuticals, Inc. (QCOR) announced it would commence a phase II study (n~210) to evaluate its marketed drug, H.P. Acthar in an additional indication. The 4-week, randomized, placebo controlled study will evaluate the safety and efficacy of the drug in patients with acute respiratory distress syndrome (a life-threatening lung condition) across multiple doses.
The U.S. Food and Drug Administration (:FDA) had reviewed Questcor's Investigational New Drug (IND) application for the indication. The IND is now active.
The primary endpoint is to determine whether treatment with Acthar increases the number of ventilator-free days during the treatment period. The secondary endpoints would check whether Acthar therapy brings down mortality, organ failure and the duration of stay in hospital or ICU.
This is the second company-sponsored IND study in 2013. Other company-sponsored studies to asses the safety and efficacy of Acthar in the treatment of amyotrophic lateral sclerosis, diabetic nephropathy, idiopathic membranous nephropathy and lupus are in progress.
Acthar, an injectable drug, is the only marketed product at Questcor. Acthar generated sales of $177 million in the second quarter of 2013. It is approved by the FDA for as many as 19 indications, including nephrotic syndrome, dermatomyositis, polymyositis, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis relapses and infantile spasms.
The company shipped 7,050 vials of Acthar during the second quarter of 2013, up 50% year over year and 46% sequentially. Acthar’s new paid prescriptions climbed 35% year over year in the second quarter of 2013.