The US Food and Drug Administration (FDA) has approved the extended-release (ER) single-entity opioid analgesic hydrocodone bitartrate (Hysingla ER, Purdue Pharma) with abuse-deterrent properties in line with the FDA’s 2013 draft guidance to industry, the agency announced.
“Hysingla ER has properties that are expected to reduce, but not totally prevent, abuse of the drug when chewed and then taken orally, or crushed and snorted or injected,” the FDA said in a statement. The tablet is difficult to crush, break, or dissolve, it notes, and forms a viscous hydrogel that cannot be easily prepared for injection.
“The FDA has determined that the physical and chemical properties of Hysingla ER are expected to make abuse by these routes difficult,” the agency adds. “However, abuse of Hysingla ER by these routes is still possible.”
“While the science of abuse deterrence is still evolving, the development of opioids that are harder to abuse is helpful in addressing the public health crisis of prescription drug abuse in the US,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the statement.
“Preventing prescription opioid abuse is a top public health priority for the FDA, and encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the agency to balance addressing this problem with ensuring that patients have access to appropriate treatments for pain,” Dr Woodcock said.
This product is indicated for treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. It is not intended for as-needed pain relief, the FDA emphasizes.
Given Hysingla ER’s risks for abuse, misuse, and addiction, it should be prescribed only to people for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient pain management, the statement adds.
The new formulation comes in 20-, 30-, 40-, 60-, 80-, 100-, and 120-mg strengths to be taken every 24 hours. Doses of 80 mg per day and higher should not be prescribed to people who have not previously taken an opioid medication, the FDA advises.
The safety and effectiveness of this product were evaluated in a clinical trial involving 905 patients with chronic low back pain. The most common adverse effects are constipation, nausea, fatigue, upper respiratory tract infection, dizziness, headache, and drowsiness.
The FDA is requiring postmarketing studies of Hysingla ER to assess the effects of the abuse-deterrent features on the risk for abuse and the consequences of that abuse in the community, the statement adds.
In addition, Hysingla ER is part of the ER/long-acting (LA) opioid analgesics risk evaluation and mitigation strategy, which requires companies to make available to healthcare professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide medication guides and patient counseling documents on the safe use, storage, and disposal of ER/LA opioids.
Hysingla ER is the second extended-release single-entity hydrocodone drug approved by the FDA. Theagency approved Zohydro ER (Zogenix Inc) in October 2013, against the advice of its own advisory committee, which expressed concerns about the potential for abuse.
The drug has been at the center of a firestorm, with consumer groups and attorneys general of numerous states asking the FDA to reverse its approval of the drug, and bills introduced in the House and Senate to keep it off the market.
One major criticism of Zohydro is that it is not available in abuse-resistant formulation. Back in September, a coalition of more than 15 consumer groups and medical experts fighting the opioid epidemic called for new leadership at the FDA, charging that the agency’s opioid policies are exacerbating the nation’s epidemic of opioid addiction and overdose deaths.