Adlon Therapeutics gets FDA green light for Adhansia XR capsules
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.”
“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.”