Injection Approved to Treat Opioid Use Disorder
The U.S. Food and Drug Administration (FDA) approved a new treatment option for patients with opioid use disorder (OUD). SublocadeTM is the first once-monthly injectable buprenorphine product for the treatment of moderate to severe OUD. Buprenorphine, the active ingredient in Sublocade, was previously approved for the treatment of OUD through administration as a tablet or film that dissolves in the mouth, or as an implant. Sublocade provides a new treatment option for patients in recovery who may value the benefits of a once-monthly injection compared to other forms of buprenorphine.
The safety and efficacy of Sublocade were evaluated in two clinical studies (one randomized control trial and one open-label clinical trial) of 848 adults diagnosed with moderate to severe OUD. Results were determined using urine drug screening and self-reporting of illicit opioid use during the 6-month treatment period. A higher proportion of patients using Sublocade had no evidence of illicit opioid use throughout the treatment period compared to patients in the placebo group.
“FDA Approves First Once-Monthly Buprenorphine Injection, a Medication-Assisted Treatment Option for Opioid Use Disorder” (2017, November 30). Retrieved December 28, 2017, from http://prn.to/2zJcj9E.
FDA Approves EKG Technology for Apple Watch®
AliveCor, the leader in personal electrocardiogram (EKG) technology, announced that the U.S. Food and Drug Administration (FDA) approved use of the KardiaBandTM in the United States. The KardiaBand allows Apple Watch® users to discreetly capture their EKG anytime, anywhere, to quickly detect normal sinus heart rhythms and atrial fibrillation (AFib), the most common heart arrhythmia. KardiaBand is the first FDA-cleared medical device accessory for Apple Watch.
AliveCor is also introducing SmartRhythm, a new feature within the Kardia app that continuously evaluates the correlation between heart and physical activity using artificial intelligence in concert with inputs from Apple Watch's heart rate and activity sensors.
Source.“FDA Clears First Medical Device Accessory for Apple Watch®” (2017, November 30). Retrieved December 28, 2017, from http://prn.to/2jaM2z2.