Trending News Today: FDA Declines Approval of Sublingual Buprenorphine Spray

Officials with the FDA have declined to approve Insys Therapeutics’ sublingual spray formulation of buprenorphine for the treatment of moderate-to-severe pain, Reuters reported. According to the article, an advisory committee to the FDA voted against the approval of the treatment in May. The FDA sent a complete response letter that indicated some of the data suggested potential safety concerns, although the spray demonstrated statistically significant pain relief compared with a placebo, the article reported.

A new study has found that Sen. Bernie Sanders’ “Medicare for all” plan would increase government health spending by $32.6 trillion over 10 years, the Associated Press reported. According to the article, the analysis found that the plan would deliver significant savings on administration and drug costs, but increased demand for care would drive up spending. Under Sanders’ plan, all US residents would be covered with no co-pays and deductibles for medical services and the insurance industry would be relegated to a minor role, the article reported.

GlaxoSmithKline’s drug Nucala received a recommendation for approval from a European Medicines Agency (EMA) panel for use in the treatment of children with severe asthma, Reuters reported. According to the article, the EMA’s Committee for Medicinal Products for Human Use recommended the drug as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients aged 6 up to 17 years old. If approved, Nucala would be the first targeted biologic therapy for the treatment of severe eosinophilic asthma in pediatric patients in Europe, the article reported.