FDA Commissioner Says FDA Will Listen to Chronic Pain Patients About Opioids

Share

The FDA approved the first non-opioid drug, lofexidine hydrochloride (Lucemyra), to help treat symptoms of opioid withdrawal in adults.

In a blog post published on Monday, Scott Gottlieb, the Food and Drug Administration commissioner, said the FDA is listening to opioid-related concerns from patients with chronic pain.

But in some cases, especially among people with opioid addiction (what the agency calls Opioid Use Disorder, or OUD), another opioid medication is substituted and its dose gradually reduced.

While there are now some other approved drugs that mitigate withdrawal symptoms, many are themselves opioids, such as buprenorphine, or target specific symptoms alongside underlying opioid dependency.

The agency stressed that Lucemyra is not specifically approved for Opioid Use Disorder, and the drug's use shouldn't extend beyond 14 days. "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". "And those who seek assistance may relapse due to continued withdrawal symptoms".

Now, the FDA is asking for input from chronic pain patients again to learn more about the "impacts of chronic pain, [patient] views on treatment approaches for chronic pain, and the challenges or barriers they face accessing treatments".

The oral, non-opioid, selective alpha 2-adrenergic receptor agonist reduces the release of norepinephrine. "I applaud the work of the FDA as well as the National Institute on Drug Abuse, which supported clinical studies of the treatment, in prioritizing efforts to prevent and treat opioid addiction".

The data showed patients treated with Lucemyra reported lower SOWS-Gossop scores vs placebo. These side effects incorporate feeling wiped out, stomach issues, muscle fits/jerking, feeling of coldness, heart beating, strong pressure, a throbbing painfulness, yawning, runny eyes and a sleeping disorder/issues dozing. When Lucemyra is stopped, patients can experience a marked increase in blood pressure.

The FDA is requiring drugmaker US WorldMeds of Louisville, Kentucky, to conduct safety studies in teens and newborns of opioid-addicted mothers and for possible longer-term use in people tapering off opioids.

The FDA allowed this application Priority Review and Fast Track assignments, and an autonomous FDA warning board bolstered the endorsement of Lucemyra at a gathering held March. The agency will also continue to evaluate how drugs now on the market are used, in both medical and illicit settings, and take regulatory action where needed.

Because Lucemyra will be available without the restrictions surrounding drugs like buprenorphine or methadone, patients potentially will be able to get it from their family doctor, Pirner told Insider.

Share