Adlon Therapeutics gets FDA green light for Adhansia XR capsules

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Adlon Therapeutics gets FDA green light for Adhansia XR capsules

By Sandra Levy - 03/13/2019
Adlon Therapeutics, a subsidiary of Purdue Pharma, has received the Food and Drug Administration’s blessing for Adhansia XR (methylphenidate hydrochloride) capsules. Adhansia XR is a central nervous system stimulant for the treatment of attention deficit hyperactivity disorder, or ADHD, in patients age 6 years old and older.

“Methylphenidate medications, when used as prescribed and in conjunction with behavioral therapy and lifestyle interventions, are one of the preferred first-line treatments for certain patients diagnosed with ADHD,” Purdue Pharma medical officer and Adlon Therapeutics general manager Marcelo Bigal said. “We are pleased to receive FDA approval for Adhansia XR, a new option for appropriate patients with ADHD who may benefit from treatment with efficacy demonstrated at one hour and 16 hours post-dose in adults, and we look forward to making it available later this year.”

“ADHD affects a significant number of adolescents and adults and, when not optimally treated, can negatively impact various aspects of their lives. A subset of these patients experience impairment throughout the day,” Purdue Pharma president and CEO Craig Landau said. “While Adhansia XR is not appropriate for all patients, a methylphenidate medication available in a single daily dose that, in adults, demonstrated efficacy at one hour and at 16 hours post dose, has the potential to address the needs of certain individuals with ADHD.”