The FDA has approved a naloxone nasal spray to stop or reverse opioid overdose. Previous versions of naloxone were only approved in injectable forms, most commonly delivered via syringe or autoinjector. Many feel the nasal spray is easier to deliver by first responders and primary caregivers, and eliminates the risk of a contaminated needle sticks. Some pharmacies have previously compounded naloxone as a nasal spray for the same indication. In clinical trials, naloxone nasal spray administered in one nostril delivered approximately the same level or higher of naloxone compared to a single dose of naloxone intramuscular injection, and achieved blood levels over the same time frame. Naloxone nasal spray is marketed as Narcan and distributed by Adapt Pharma Inc. The nasal spray is priced at $37.50 per dose for large group purchasers such as government, community, and education organizations, including law-enforcement, fire departments, and schools. This is less expensive than the injectable version.
An FDA panel recommends stronger warning labels on fluoroquinolones (ciprofloxacin, levofloxacin, and others) regarding the risk of cardiac arrhythmia, peripheral neuropathy, tendinopathy, and cognitive problems. The drugs are commonly used to treat sinus infections, urinary tract infections, and bronchitis complicating chronic obstructive pulmonary disease. The FDA’s Drug Safety and Risk Management Advisory Community and Antimicrobial Drugs Advisory Community made the recommendations. The FDA usually endorses its committee’s recommendations.
The FDA has approved a new once-daily, fixed-dose combination pill for treating HIV-1 infection. The pill combines elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (a new formulation of tenofovir) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients ≥ 12 years of age. The new formulation of tenofovir is thought to reduce toxicity of the drug while maintaining efficacy. The combination’s safety and efficacy were evaluated in 3171 patients enrolled in four clinical trials and showed comparability to other treatments in reducing viral loads. The new combination is marketed by Gilead as Genvoya.