Hysingla ER (hydrocodone bitartrate), an extended release (ER) opioid analgesic has received an approval by the FDA .It is the product of the company Purdue Pharma L.P. The drug will act as a treatment for people for whom the alternative options are inadequate and require daily, around the clock pain relief treatment.
The approval has alarmed some addiction experts who fear that its widespread use may contribute to already alarming rise in abuse of prescription drug leading to its overdoses.
In a statement issued by the CEO Mark Timney of Purdue Pharma “We are proud to offer healthcare professionals and chronic pain patients another treatment option.”
He says that “Hysingla ER is the third product in our pain management portfolio to receive an FDA label describing its abuse-deterrent characteristics. These innovations are an important step forward in helping meet patients’ needs while also working to deter misuse and abuse.”
The properties of Hysingla ER aim at reducing but not totally preventing the abuse of the drug. The tablet is difficult to crush, break or dissolve as it forms a viscous hydrogel (thick gel) and cannot be easily prepared for injection.
Since consuming the drug by these routes due to its physical and chemical properties is not possible, according to the FDA the abuse of Hysingla is difficult.
It is important to keep in mind that consuming too much of Hysingla ER, whether by intentional abuse or by accident might lead to an overdose resulting into death.
The director of the FDA’s Center for Drug Evaluation and Research Janet Woodcock (M.D.) said that “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 U.S.”
He further added that:
“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.”
Given the risks for abuse, misuse and addiction, Hysingla ER should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management.
It can also be noted that Hysingla ER (hydrocodone) does not have any risks associated with serious liver toxicity when used in combination with products containing acetaminophen. The FDA encourages health care professionals to review and consider all available information as part of their decision-making when prescribing opioid analgesics.
Strengths of Hysingla ER: 20, 30, 40, 60, 80, 100 and 120 milligrams (mg) of hydrocodone to be taken every 24 hours.
Dosage higher than 80 mg per day is not to be prescribed to people who have not taken an opioid medication before (opioid non-tolerant).
The safety and efficacy of Hysingla ER was evaluated in a clinical trial of 905 people with chronic low back pain. The most common side effects of Hysingla ER in the participants were found to be constipation, nausea, fatigue, upper respiratory tract infection, dizziness, headache and drowsiness.
The FDA is requires post marketing studies with respect to Hysingla ER to assess the effects of the abuse-deterrent features on the risk for abuse of Hysingla ER and the consequences of that abuse in the community.
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About Ruchira Dhoke
A qualified medical microbiologist with an avidity to read enchant a deep passion for creating a good impacting masterpiece with my words .I am very fond of good old English literature and like listening to music and paint in my free time.
