Opioid Use: Non-opioid Tablet for Withdrawal Symptoms Available as FDA Encourages Treatment Medication Development

The FDA is encouraging the development of novel medication-assisted treatment drugs for individuals with opioid use disorder (OUD), while the first non-opioid medication indicated for the reduction of opioid withdrawal symptoms has been made available to the market.

Approved by FDA officials in May, lofexidine (Lucemyra, US WorldMeds and Salix Pharmaceuticals), is available for prescription in 0.18-mg tablets.¹ The medication is not intended to treat opioid withdrawal but rather assist individuals with the discontinuation of opioid use by managing withdrawal symptoms.¹

Physical dependence to opioids is an expected physiological response to opioid use. Withdrawal symptoms, such as agitation, anxiety, diarrhea, drug craving, muscle aches, nausea, runny nose, sleep problems, and vomiting, can occur after reducing or stopping the use of opioids, in an individual with physical dependence. Symptoms of opioid withdrawal occur in patients who have been using opioids appropriately as prescribed and in patients with OUD.²

Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine. The actions of norepinephrine in the autonomic nervous system are thought to play a role in many of the symptoms of opioid withdrawal.²

"Many people who wish to stop taking opioids are searching for a treatment that will help get them through the agonizing symptoms of withdrawal," P. Breckinridge Jones, chief executive officer and founder, US WorldMeds, said in a statement.¹ "The availability of Lucemyra broadens the range of evidence-based pharmacological options available to health care providers, so they can manage the challenges of withdrawal and facilitate their patients' abrupt discontinuation of opioids."

In bringing Lucemyra to the pharmaceutical market, US WorldMeds and Salix Pharmaceuticals also announced a co-pay program that is designed to help provide the medication to eligible patients for a price as low as $25.¹

Most pharmacies in the United States are covered through the co-pay program, according to the companies.

Meanwhile, the FDA announced the availability of new scientific recommendations that are being used to encourage development of novel medicines to treat opioid use disorder.

In a statement, FDA officials discussed the agency’s new draft guidelines that outline ways for drug developers to consider measuring and demonstrating the benefits and effectiveness of medication-assisted treatments.³

“As we seek to help those with an opioid use disorder transition to lives of sobriety, we recognize there’s great interest in new treatment options that result in meaningful outcomes for patients. For example, we must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission,” FDA Commissioner Scott Gottlieb, MD, said in the statement.³

“Treatments that can impact these aspects of addiction can be important parts of a comprehensive approach to the treatment of opioid use disorder. This new guidance is an important step in fostering the development of new treatment options that help patients achieve these and other real-world outcomes, by providing a pathway for how innovators can use these clinically relevant measures as part of new drug development programs,” Gottlieb said.³

“We’re committed to doing our part to expand access to high-quality, effective medication-assisted treatments and encouraging health care professionals to ensure patients with opioid use disorder are offered an adequate chance to benefit from these therapies,” he said.³ “This work also includes improving understanding about the treatment options available for patients and countering the unfortunate stigma that’s sometimes associated with their use.”

Clinical trials to evaluate the effectiveness of medication-assisted therapy (MAT) for the purposes of FDA approval have generally used reduction in drug-taking behavior as an endpoint.³ The new draft guidance, “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment,” identifies several additional potential clinical endpoints and other outcome measures that drug developers may consider.³

One example is encouraging drug sponsors to consider a variety of ways to evaluate the clinical benefit and effect of MAT. These include the impact of a new drug on adverse outcomes such as emergency medical interventions, hepatitis C seroconversion, and mortality.³

Efficacy may also be measured by studying the proportion of patients who transition from meeting criteria for being diagnosed with moderate to severe OUD, based on both drug use and its impact on patient well-being, at baseline to being considered in remission at the end of the study.³

Improvements in the ability to resume work, school, or other productive activity may also demonstrate clinical benefit, according to the FDA.³

References

• US WorldMeds and Salix Announce U.S. Launch of LUCEMYRA™ (lofexidine) 0.18 Mg Tablets [news release]. Louisville, KY and Bridgewater, NJ; August 6, 2018: US WorldMeds Media. https://prnmedia.prnewswire.com/news-releases/us-worldmeds-and-salix-announce-us-launch-of-lucemyra-lofexidine-0-18-mg-tablets-300692173.html. Accessed August 6, 2018.
• FDA Approves First Non-opioid Treatment for Management of Opioid Withdrawal Symptoms in Adults. Pharmacy Times. www.pharmacytimes.com/news/fda-approves-first-nonopioid-treatment-for-management-of-opioid-withdrawal-symptoms-in-adults. Published May 16, 2018. Accessed August 6, 2018.
• FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder [news release]. Silver Spring, MD; August 6, 2018: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615892.htm. Accessed August 6, 2018.