Dive Brief:
- Salix Pharmaceuticals, a division of Valeant Pharmaceuticals, has snapped up exclusive copromotion rights to US WorldMeds' Lucemyra, the only non-opioid approved in the U.S. for management of abrupt opioid withdrawal. Financial terms were not disclosed.
- Lucemyra's approval for 14 days of treatment is based on two randomized, double-blind, placebo-controlled clinical trials of 866 adults. The scores of the patient outcome measure Short Opiate Withdrawal Scale of Gossop were lower in patients taking Lucemyra compared with placebo, and more patients completed the treatment period.
- The approval requires 15 animal and human postmarketing studies. These will look at longer term use, safety aspects and use in children, including newborns with neonatal opioid withdrawal and children stopping medically-required opioids.
Dive Insight:
According to the National Institutes of Health, more than two million people in the U.S. have opioid use disorder, with millions more abusing opiates. Without treatment, opioid withdrawal symptoms can peak at around 72 hours and include drug craving, nausea and vomiting, diarrhea, muscle cramps, stomach cramps, pupil dilation, depression and goosebumps. Psychological symptoms and cravings may last for more than a week, and overall withdrawal is so unpleasant that people often return to taking opioids to stop the pain.
The FDA cleared US WorldMeds' Lucemyra (lofexidine) in May in adults who have suddenly stopped taking opioids, with an aim to control their withdrawal symptoms.
"Research indicates that withdrawal fear is contributing to the U.S. opioid public health issue. We believe an important step in addressing this epidemic is to empower patients with the ability to endure opioid withdrawal and provide a starting point towards recovery," said Mark McKenna, SVP and general manager at Salix in a statement.
While Lucemyra, an oral, selective alpha 2-adrenergic receptor agonist, does not prevent the symptoms, it does lessen them, and can be used as part of a broader long-term opioid use disorder management plan. Salix aims to be able to bring Lucemyra to a wider market, and support physician and patient education around opioid withdrawal.
"Partnering with Salix, which has a strong commercial presence in primary care and pain management, will provide greater momentum and broader reach for the launch and uptake of Lucemyra," said P. Breckinridge Jones, CEO of US WorldMeds in a statement.
Support for medication-assisted treatment for opioid use disorder is growing.
Medicare, Medicaid and Affordable Care Act insurance exchanges all offer medication-assisted treatment programs. Overall, opioid supply levels have declined in most states in the U.S. with safe opioid prescribing policies cutting the number of Medicare recipients getting higher-than-recommended doses of opioids from multiple doctors in 2017, and doctors themselves prescribing fewer opioids.
The FDA is also part of the opioid reduction campaign. It has launched an innovation challenge encouraging the development of medical devices such as digital health applications and diagnostic tests.