FDA approves first once-monthly buprenorphine injection
The FDA approved buprenorphine extended-release (ER) (Sublocade), the first once-monthly buprenorphine subcutaneous injection. Buprenorphine ER, a partial opioid agonist, is approved as treatment for moderate-to-severe opioid use disorder in adult patients who have initiated treatment with a transmucosal buprenorphine-containing product with dose adjustment for a minimum of 7 days. The drug should be used as part of a comprehensive treatment plan that includes counseling and psychosocial support.
Buprenorphine ER provides a new treatment option for patients in recovery who may value the benefits of a once-monthly subcutaneous injection compared with other forms of buprenorphine, including a sublingual tablet, buccal film, transdermal system, and subdermal implant.
In clinical trials, buprenorphine ER provided sustained therapeutic plasma levels over the 1-month dosing interval, and patients treated with buprenorphine ER had more weeks without positive urine tests or self-reports of opioid use. A higher proportion of patients had no evidence of illicit opioid use throughout the treatment period compared with the placebo group.
Buprenorphine ER is available through a restricted program and is administered in a healthcare setting only by healthcare providers who meet the qualifying requirements. The drug has a box warning stating that serious harm or death may result if the drug is given via the I.V. route.
The most common adverse reactions associated with buprenorphine ER include: constipation, nausea, vomiting, headache, drowsiness, injection site pain, pruritus at the injection site, and abnormal liver function tests.
Sublocade is a product of Indivior Inc.
FDA approves expanded indication and new formulation for aliskiren
The FDA approved Noden Pharma's aliskiren (Tekturna) 37.5 mg oral pellets for the treatment of hypertension (HTN) in adults and children age 6 and older. The expanded indication and new formulation provide an additional option for treating pediatric patients with HTN.
The oral pellets are provided in a dispensing capsule that must not be swallowed; the contents of the capsule must not be emptied directly into the mouth. The capsules should be opened and the contents emptied onto a spoon and then placed in the mouth, followed immediately with milk (dairy or soy-based) or water and the combination of pellets and liquid swallowed without chewing or crushing the pellets. The contents of the dispensing capsule may also be mixed with 1 teaspoon or more of vanilla pudding (milk or soy-based), vanilla ice cream (milk or soy-based), milk (dairy or soy-based), or water as a dosing vehicle. Patients should be instructed to establish a regular pattern of taking the drug with regard to meals.
The safety and efficacy of aliskiren oral pellets for pediatric use was evaluated in an 8-week randomized, double-blind clinical trial in 267 hypertensive patients ages 6 to 17 years. During the initial dose-response phase, aliskiren reduced both systolic and diastolic BP in a weight-based, dose-dependent manner. Following the 8-week study, 208 patients were enrolled in a 52-week extension trial in which patients were randomized to either aliskiren or enalapril. At the end of 52 weeks, reductions in BP from baseline were similar in patients receiving aliskiren (7.6/3.9 mm Hg) and enalapril (7.9/4.9 mm Hg).
Golimumab approved for PsA and AS
Janssen Biotech announced that the FDA approved golimumab (Simponi Aria) for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). Golimumab, an antitumor necrosis factor-alpha therapy, was previously approved for the treatment of moderately to severely active rheumatoid arthritis.
The expanded indication was supported by clinical data from two-phase III trials (GO-VIBRANT and GO-ALIVE) in over 600 patients. In both studies, there was a higher proportion of patients showing significant improvement in the signs and symptoms of PsA and AS in the golimumab arm versus placebo.
The prescribing information for golimumab has a box warning indicating that patients treated with golimumab are at increased risk for malignancy and serious infections including tuberculosis.