Adhansia XR Is Granted a Controversial Approval for ADHD Treatment

Adhansia XR (methylphenidate hydrochloride) was given approval by the FDA for the treatment of ADHD in patients 6 years old and older, after a simulated adult workplace environment study was found to be positive. According to Aldon Therapeutics, the manufacturer of Adhansia XR and a subsidiary of Purdue Pharmaceuticals, the drug showed statistically significant improvement over placebo at 1, 2, 5, 8, 11, and 16 hours post-dose, but not at hour 14 post-dose.

Marcelo Bigal, MD, PhD, chief medical officer, Purdue Pharma, and general manager of Adlon Therapeutics elaborated on the findings saying, “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.” However, methylphenidate comes with a great risk of abuse. Adhansia XR comes with a boxed warning for abuse and dependence of this drug and that healthcare providers need to assess the risk of abuse a patient may have before prescribing Adhansia XR.

Some believe that Adhansia XR is just simply another methylphenidate with a higher dosage and only has no therapeutic equivalents mainly due to its 16-hour mechanism. A mechanism that has the potential to be harmful for younger pediatric patients. According to Dr. Andrew J. Cutler, chief medical officer of Meridien Research and an investigator on Adhansia XR trials stated his excitement for the drug saying, “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. The approval of Adhansia XR offers a methylphenidate treatment option with a longer duration of efficacy, which may be appropriate for these patients.” However, in a separate interview he cautioned that when it comes to pediatric patients at the age of 6, “a drug that lasts 16 hours may not be appropriate for children that young.”

Other experts and leaders in the field believe that this could lead to a vicious cycle of the patient wanting to take more of the drug and the clinician providing it to them at their request. Some went so far to say that this new drug is only meant to secure another patent on the drug and raise prices. Much of this skepticism stems from the fact that Aldon Therapeutics’ parent company Purdue Pharmaceuticals is facing numerous lawsuits over its marketing of OxyCotin that many allege has, in part, led to the current opioid crisis. Purdue Pharmaceuticals has even recently settled on one of its over 1,600 pending lawsuits that allege the company’s aggressive OxyCotin marketing has played a major part in today’s opioid crisis.

Adlon Therapeutics has responded to these worries surrounding its new drug by stating it has no plans to use direct-to-consumer advertising, rather focusing on “responsible and transparent interactions with the professional community to address needs in the existing population of appropriately-diagnosed patients. Ensuring the responsible prescribing and use of Adhansia XR is a priority.”

Craig Landau, MD, president and CEO, of Purdue Pharma elaborated on this in the approval press release saying, “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. 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.”

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