First Single-Entity Extended-Release Hydrocodone gets FDA’s thumbs up

People suffering from acute pain may now get some respite! The single-entity extended-release hydrocodone bitartrate formulation has gained the approval from the FDA. This prepared formulation also called as Zohydro ER, Zogenix Inc, maybe the only way out for providing relief to people having severe pain that lasts throughout the day and night that cannot be controlled with any alternative options.

FDA statement

The single-entity extended-release hydrocodone bitartrate formulation may provide relief to the people caught in the throes of pain and suffering all the time.

The FDA released a note on the matter stating “Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product. Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids.”

The drug safety was checked through clinical trials conducted on about 1100 patients suffering from chronic pain. The drug efficacy depended on data collected from about 500 people having severe chronic low back pain. The drug showed an amazing improvement when compared against chronic pain v/s the placebo.

More about The hydrocodone bitartrate

The hydrocodone bitartrate formulation is a member of the extended-release/long-acting (ER/LA) opioids and can lead to addiction and maybe misused. Even the recommended dose may lead to the abuse of the drug.

In the past the drug abuse due to opiods overdose has resulted in deaths so FDA states “Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”

The drug possesses the updated requirements for labeling as suggested by FDA for the ER/LA opioids. These labeling will carry the warnings, and risks carefully mentioned so that proper use of these medicines is done. “These warnings are expected to improve the safety of all such medicines by encouraging more appropriate prescribing, patient monitoring, and patient counseling practices,” says the FDA.

The refills of the Schedule II drugs will not be permitted and they can be purchased only by proper prescription. The drug will require proper reporting, physical security requirements and Stringent record-keeping

FDA aspires for proper post marketing knowledge to analyze the “serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death associated with long-term use beyond 12 weeks.” This was confirmed by the FDA release.

The ER/LA Opioids Analgesics risk evaluation and mitigation strategy (REMS) of 2012 insists on some educational programs on dispensing these agents safely to the healthcare professionals.

Side effects of drug

The single-entity hydrocodone does cause nausea, constipation, somnolence, headache, fatigue, dizziness, vomiting, pruritis and dry mouth as side effects.

Most of The members of the FDA’s Anesthetic and Analgesic Drug Advisory Committee of independent experts gave the thumbs up as far as the safety and efficacy of the drug was concerned but the approval of the application was in doldrums as the “abuse quotient” of the medication was questionable.