Adhansia XR Approved to Treat ADHD
February 27, 2019 – The U.S. FDA has approved Adhansia XR™ (methylphenidate hydrochloride) extended-release capsules, manufactured by Adlon Therapeutics, to treat attention deficit hyperactivity disorder (ADHD) in patients who are at least six years of age. The product is a Schedule II controlled substance.
Methylphenidate, the active ingredient in Adhansia XR, is a frequently used first-line treatment for ADHD, in combination with behavioral therapy and lifestyle interventions. Adhansia XR’s extended release formula may help certain patients with ADHD maintain attention throughout the day. In clinical studies, patients who received Adhansia XR experienced statistically significant improvement compared to placebo at Hours 1, 2, 5, 8, 11, and 16 post-dose, but not at Hour 14.
Recommended dosing is 25mg taken once daily each morning, and can be increased by 10-15mg every five days or more if needed. Doses that exceed 85mg a day for adults or 70mg a day for children are associated with disproportionate increases in the incidence of side effects. Adhansia XR will be available in capsule form in six different strengths. The capsules can be swallowed whole, or opened and sprinkled on a tablespoon of applesauce or yogurt. To avoid dosing errors, Adhansia XR should not be substituted for other methylphenidate products on a milligram-per-milligram basis. A black box warning cautions that CNS stimulants like Adhansia XR can carry a high risk of abuse and dependency.
Launch and pricing plans have not yet been announced.