This would be the first and only non-opioid, non-addictive medication for management of opioid withdrawal.
The US Food and Drug Administration (FDA) has accepted and granted priority review of the New Drug Application (NDA) for lofexidine to mitigate symptoms associated with opioid withdrawal and facilitate completion of opioid discontinuation treatment, announced US WorldMeds.
The NDA submission is supported by 2 clinical trials and several supporting studies that characterized the safety of the product in more than 1,000 patients.
“Fear of opioid withdrawal can deter individuals from seeking care," Mark Pirner, MD, PhD, senior medical director, clinical research, told MD Magazine. "Further, ineffective or partial withdrawal management can drive individuals to abandon their attempts to transition to their next steps of recovery. Effective and safe management of opioid withdrawal symptoms is vitally important to engage and keep individuals in treatment and recovery. If approved, lofexidine has the potential to provide meaningful relief for anyone suffering from symptoms of opioid withdrawal and seeking to successfully discontinue opioid use.”
The development also involved an extensive clinical pharmacology program including studies investigating concomitant administration of lofexidine with methadone, buprenorphine and naltrexone.
In its trials, it significantly reduced the severity of withdrawal symptoms compared to placebo, as reported by patients undergoing withdrawal.
The potential treatment is in development for the mitigation of symptoms associated with opioid withdrawal and facilitation of completion of opioid discontinuation treatment.
“The symptoms of withdrawal are agonizing and present a significant barrier to successful opioid discontinuation,” Pirner noted. “Opioid withdrawal is an important step that everyone at risk of physical dependence or addiction to opioids must face in their journey to discontinue opioids or bridge to other treatment and recovery steps.”
The oral tablet is a selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine which supports vital functions like respiration and consciousness. With repeated opioid use, the brain establishes a new equilibrium by increasing compensatory norepinephrine production to maintain normal functioning. When the opioid is removed or doses are reduced, the levels are no longer offset by opioid presence and therefore a surge results, producing the acute, and painful withdrawal symptoms.
“The FDA’s decision to grant priority review to our lofexidine NDA highlights the critical role withdrawal management plays in the urgent need to address opioid abuse and misuse,” added Pirner.
The Prescription Drug User Fee Act (PDUFA) date is set to occur during the second quarter of 2018.
A press release has been made available.