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Trending News Today: FDA Advisory Panel Votes Against Depression Treatment

Top news of the day from across the health care landscape.
 
Published Online: Nov 02,2018
AJPB Staff
Epidiolex, the first cannabis-derived medication approved by the FDA, is now available by prescription in every state, The Hill reported. According to the article, Epidiolex is indicated to treat seizures associated with 2 rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients 2 years and older. The treatment was approved by the FDA in June and classified by the DEA as a Schedule V substance, the least restrictive schedule of a controlled substance, the article reported.

An advisory panel to the FDA voted against approving ALKS 5461, Alkermes’ depression treatment, for patients with an inadequate response to standard antidepressant therapies, Reuters reported. According to the article, FDA staff reviewers raised concerns about abuse potential for the opioid-based treatment and questioned its efficacy prior to the decision. The panel voted 21-2 against the drug, saying the data did not support a favorable benefit-risk profile, the article reported.

A new Congressional report indicates that several factors, such as the rebate system, lead to artificially high prices for insulin products, as well as limited competition in the market, The Hill reported. According to the article, co-chairs of the Congressional Diabetes Caucus, Reps. Diana DeGette (D-Colo) and Tom Reed (R-NY), recommended a legislative response to the rising prices of insulin that focus on generating more competition and creating pricing transparency. Specifically, they recommended reforming the rebate system by introducing legislation requiring wholesalers to use standardized fees instead of rebates based on list prices, as well as requiring drug plans in federal health programs to disclose how much money they receive from rebates, the article reported.