Trending News Today: FDA Declines to Approve Opioid-based Depression Treatment

Officials with the FDA declined to approve Alkermes Plc’s opioid-based depression treatment, ALKS 5461, Reuters reported. According to the article, the FDA cited the need for additional data to prove the efficacy of the drug, a once-daily pill combining samidorphan and buprenorphine designed as an add-on treatment for patients with major depressive disorder. The decision comes months after an advisory panel to the FDA voted against the drug’s approval, the article reported.

A new study found that out-of-pocket clinical costs and capitalized clinical costs per approved drug were both lower for orphan drugs compared with non-orphan drugs, The American Journal of Managed Care reported. According to the article, the study included data from 1163 trials with 561 non-orphan drugs and 602 orphan drugs. The study showed that the overall cost of orphan drug development is less than that of non-orphan drug development, the article reported.

An analysis of price lists from the largest acute care hospitals in several large cities showed that prices varied widely on some basic procedures, even for basic charges, Kaiser Health News reported. According to the article, one example showed that the list price on a liter of basic saline solution for intravenous use ranged from $56 to $472.50 and a brain MRI with contrast was priced from $1720 to $8800. The analysis also found that the prices varied widely even compared with nearby hospitals, the article reported.