Questcor Pharmaceuticals, Inc.
) 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.
Questcor carries a Zacks Rank #3 (Hold). Currently, companies
Isis Pharmaceuticals, Inc.
) look more attractive with a Zacks Rank #1 (Strong Buy).
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