#1 FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults
In a press release on May 16, 2018, the FDA announced their approval of Lucemyra (lofexidine hydrochloride) for “the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.” The drug was granted Priority Review and Fast Track designations and its approval is for a treatment period up to 14 days. The release noted that while Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and it is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD.
The press release included the following statement from the FDA Commissioner. “As part of our commitment to support patients struggling with addiction, we’re dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids,” said FDA Commissioner Scott Gottlieb, M.D. “We’re developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms. We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help. And those who seek assistance may relapse due to continued withdrawal symptoms. The FDA will continue to encourage the innovation and development of therapies to help those suffering from opioid addiction transition to lives of sobriety, as well as address the unfortunate stigma that’s sometimes associated with the use of medication-assisted treatments.”
Approval for Lucemyra was granted to US WorldMeds LLC.
#2 FDA approves novel preventive treatment for migraine
Following the approval announcement of the first non-opioid treatment for the management of withdrawal symptoms in adults, on May 17, 2018 the FDA put out a press release approving Aimovig (erenumab-aooe) for “the preventive treatment of migraine in adults.”
The press release included the following statement from an official in the FDA’s CDER branch. “Aimovig provides patients with a novel option for reducing the number of days with migraine,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We need new treatments for this painful and often debilitating condition.”
This is good news for the millions of Americans who suffer debilitating pain from migraine headaches including the 15% who are prescribed opioid painkillers. However, the first-in-class drug comes with a price tag of $6,900 and needs health insurance companies to come onboard.
Approval for Aimovig was granted to Amgen Inc.