New medication approved for COPD
The FDA has approved glycopyrrolate and formoterol fumarate (Bevespi Aerosphere) inhalation aerosol, the first long-acting muscarinic antagonist and long-acting beta2-agonist combination in a pressurized metered-dose inhaler (pMDI) for chronic obstructive pulmonary disease (COPD). The twice-daily, oral inhalation, fixed-dose combination of glycopyrrolate and the long-acting beta2-agonist formoterol fumarate is indicated for the long-term maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and/or emphysema. It is not indicated for the treatment of asthma or to relieve acute bronchospasm.
Bevespi Aerosphere was approved based on data from the PINNACLE trial program, which enrolled over 3,700 patients with moderate-to-very-severe COPD. The trials demonstrated that the medication achieved statistically significant improvement in morning predose forced expiratory volume in 1 second (FEV1) at 24 weeks (P less than 0.001) versus its mono-components and placebo.
The most common adverse reactions with Bevespi Aerosphere include urinary tract infection and cough.
FDA approves abuse-deterrent, long-acting oxycodone
Oxycodone extended-release (ER) capsules (Xtampza ER), a twice-daily, abuse-deterrent oxycodone medication, was approved by the FDA for managing chronic pain requiring daily, around-the-clock, long-term opioid treatment for which alternatives are inadequate. The medication is a product of Collegium Pharmaceutical Inc.
The drug uses Collegium's proprietary DETERx technology, which is designed to provide adequate pain control while maintaining its drug-release profile after being subjected to manipulation, such as chewing and crushing.
Xtampza ER also allows prescribers to use flexible dosing in patients who have difficulty swallowing, a danger with currently marketed ER products. Xtampza ER can be given by breaking open the capsule and pouring the oxycodone microspheres into a feeding tube, or sprinkling them on soft food or directly into the mouth. The drug must be taken with approximately the same amount of food with each dose to ensure consistent plasma levels.
Xtampza ER has a Black Box Warning for addiction, abuse and misuse, life-threatening respiratory depression, accidental ingestion, neonatal opioid withdrawal syndrome, and cytochrome P450 3A4 interactions.
Breath-actuated inhaler now approved for younger children
The FDA approved the expanded indication for Teva's short-acting beta2-adrenergic agonist albuterol sulfate inhalation powder (ProAir RespiClick) for use in children ages 4 to 11. The product is now indicated for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for prevention of exercise-induced bronchospasm in patients age 4 and older.
The approval follows the FDA's review of data from a phase III clinical trial that evaluated the safety and efficacy of the treatment in patients with asthma as young as age 4; the trial showed that treatment with ProAir RespiClick led to significantly greater improvement in forced expiratory volume compared with placebo.
Common adverse reactions reported in patients ages 4 to 11 include upper respiratory infections, mouth and throat pain, and vomiting.
Extended-release oral suspension ADHD medication available
The first and only extended-release amphetamine liquid oral suspension amphetamine (Dyanavel XR) is available in U.S. pharmacies for the treatment of attention deficit hyperactivity disorder (ADHD) in children age 6 and older. Dyanavel XR is a CII controlled substance and was approved in October 2015. It is a product of Tris Pharma.
The once-daily liquid allows prescribers to customize the dose appropriately for each child with ADHD.
The most common adverse reactions reported in the Phase III controlled trial were epistaxis, allergic rhinitis, and upper abdominal pain.
Consult product labeling for more important prescribing information, including a warning for the potential risk of abuse and dependence.