FDA News

FDA approves Adhansia XR for ADHD

Andrew J. Cutler, MD
Andrew J. Cutler

The FDA has approved Adhansia XR extended-release capsules CII, a central nervous system stimulant, for the treatment of ADHD in certain patients aged 6 years and older, according to a press release.

However, Adhansia XR (methylphenidate hydrochloride; Adlon Therapeutics LP) is not appropriate for all patients, the release cautioned.

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,” Marcelo Bigal, MD, PhD, chief medical officer, Purdue Pharma, and general manager, Adlon Therapeutics, said in the release.

Adhansia XR contains a boxed warning for abuse and dependence, according to the release. Health care professionals should work with their patients to figure out the best treatment option, evaluate the risk of abuse before prescribing Adhansia XR and monitor for signs of abuse and dependence while patients receive treatment.

In a simulated adult workplace environment study, treatment with Adhansia XR yielded statistically significant improvement compared with placebo at 1 hour and at 16 hours post-dose, according to the release. The FDA approval of Adhansia XR was based on four clinical studies evaluating its efficacy and safety in adult and pediatric (aged 6 to 17 years) patients with ADHD.

The medication will be available in six capsule strengths — 25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg — to enable flexible dosing; however, the recommended starting dose for patients 6 years or older is 25 mg once daily, according to the release.

“Some of my patients with ADHD, especially those who are balancing school or work and participating in social or civic activities, require the ability to sustain attention throughout the day,” Andrew J. Cutler, MD, chief medical officer, Meridien Research, and an investigator on Adhansia XR clinical studies, said in the release. “The approval of Adhansia XR offers a methylphenidate treatment option with a longer duration of efficacy, which may be appropriate for these patients.”

Andrew J. Cutler, MD
Andrew J. Cutler

The FDA has approved Adhansia XR extended-release capsules CII, a central nervous system stimulant, for the treatment of ADHD in certain patients aged 6 years and older, according to a press release.

However, Adhansia XR (methylphenidate hydrochloride; Adlon Therapeutics LP) is not appropriate for all patients, the release cautioned.

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,” Marcelo Bigal, MD, PhD, chief medical officer, Purdue Pharma, and general manager, Adlon Therapeutics, said in the release.

Adhansia XR contains a boxed warning for abuse and dependence, according to the release. Health care professionals should work with their patients to figure out the best treatment option, evaluate the risk of abuse before prescribing Adhansia XR and monitor for signs of abuse and dependence while patients receive treatment.

In a simulated adult workplace environment study, treatment with Adhansia XR yielded statistically significant improvement compared with placebo at 1 hour and at 16 hours post-dose, according to the release. The FDA approval of Adhansia XR was based on four clinical studies evaluating its efficacy and safety in adult and pediatric (aged 6 to 17 years) patients with ADHD.

The medication will be available in six capsule strengths — 25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg — to enable flexible dosing; however, the recommended starting dose for patients 6 years or older is 25 mg once daily, according to the release.

“Some of my patients with ADHD, especially those who are balancing school or work and participating in social or civic activities, require the ability to sustain attention throughout the day,” Andrew J. Cutler, MD, chief medical officer, Meridien Research, and an investigator on Adhansia XR clinical studies, said in the release. “The approval of Adhansia XR offers a methylphenidate treatment option with a longer duration of efficacy, which may be appropriate for these patients.”