FDA greenlights Louisville company's drug for opioid withdrawal

FDA greenlights Louisville company's drug for opioid withdrawal

The Food and Drug Administration (FDA) has approved Lucemyra (lofexidine HCl; US WorldMeds) for the mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.

In a statement, FDA Commissioner Scott Gottlieb said the approval was a positive development in the agency's continued effort to help people overcome opioid addiction.

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. Announcing the move in a press statement yesterday (May 16), the agency noted that Lucemyra (lofexidine hydrochloride) is meant to help adults who abruptly stop taking the addictive painkillers, and is only approved for treatment for up to two weeks. Additionally, the therapy has not been approved to treat opioid use disorder, but is meant to be used as part of a long-term treatment plan for the condition. The specialty pharma was not granted approval to treat opioid use disorder, but instead to treat symptoms of withdrawal. Plus, patients who got Lucemyra were more likely to complete the course of treatment, which can only last for up to 14 days. The wellbeing and viability of Lucemyra have not been built up in kids or young people under 17 years old. This hormone is believed to play a role in symptoms of opioid withdrawal, the FDA said. Common side effects include a slow heart rate, low blood pressure, and sleepiness. Compared to the placebo group, patients treated with Lucemyra reported a lower severity of symptoms. Lucemyra was additionally connected with a couple of instances of syncope (blacking out).

The FDA is requiring 15 post-marketing studies - or studies that happen after a drug is approved. Animal safety studies will look at the drug's longer-term use and its use in children, the agency said. They include both animal and human studies. Clinical studies will be required to evaluate the safety of Lucemyra in clinical situations where use could be expected to exceed the maximum 14-day treatment period for which the product is now approved, such as gradual opioid taper; to gather additional safety data on the effects of lofexidine on the liver; and to further characterize the effects on blood pressure after lofexidine is stopped. In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren't over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments.

Privately held US WorldMeds said it had not yet set a price for Lucemyra.