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FDA approves the Hydrocodone Pain killer – Zohydro ER
The pain killer Zohydro ER (Hydrocodone bitartrate), the extended release capsules by Zogenix got approval from the Food and Drug Administration on 25th October 2013 leaving behind many criticisms. The reason is that the hydrocodone, the main ingredient of the pain killer Zohydro ER is classified under opiate/opiod group of drugs for its structural resemblance to the opium and also recognized as the abused pain killer by Drug Enforcement Administration (DEA).

Though a hydrocodone combination of painkillers already exists in the market, Zohydro ER gets the status of the first drug with pure hydrocodone, ultimately being the cause of reluctance in acceptance of its approval by many individual bodies like patient safety advocates, pain specialist panel and community groups functioning towards protecting youths from pain killer addiction. Even there was a negative feedback on drug review from FDA’s own advisory panel previous year.

Taking all these into account FDA has taken steps to ensure the safe use of the drug. A day before the approval, FDA suggested enlisting the hydrocodone in schedule II drugs and accordingly FDA stated that the sale of the drug Zohydro ER will stick to schedule II drugs regulations. FDA has also instructed Zogenix, to keep a continuous check on the usage of the drug in the market.

Being the manufacturer of the drug Zohydro ER, the need and responsibility of Zogenix to ensure the safe use of the drug is high. As a result Zogenix has implemented several programs like Risk evaluation and Mitigation Strategy and integrated educational resources (on the drug) exclusively for patients, doctors and pharmacists and a drug surveillance program. Zogenix is also committed to carry out post market studies on the drug Zohydro ER and also into the process of making abuse deterrent formulation for the drug.

With all the controversies and compliments the hydrocodone drug designed in six different dosages to relieve patients from the long term severe pain has influenced a raise in the company’s shares following its approval. However the dignity of the drug in the market should be ensured by sticking to the guidelines framed by FDA and the commitment made by Zogenix .
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