Stamford, CN, United States (4E) – The Food and Drug Administration (FDA) is giving priority review to a painkiller tablet designed to deter abuse by not being easily snorted or injected.
The priority review for Purdue Pharma LP’s hydrocodone bitartrate tablet (HYD) means the FDA will decide on the company’s approval application within six months instead of the standard 10-month period.
If approved, HYD will be the first painkiller with an “abuse-deterrent formula” that makes it harder for the drug to be crushed or liquefied.
“This is another milestone in our effort to offer patients and health professionals a portfolio of pain medications with abuse-deterrent technology,” Mark Timney, President and CEO of Purdue Pharma, said in a press statement early this month.
Purdue announced filing the New Drug Application (NDA) for HYD in April and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of October 2014.
Dr. Todd Baumgartner, vice president of regulatory affairs and chief medical officer of Purdue Pharma, said that if approved by the FDA, the tablet “will be a valuable therapy for treating chronic pain.”
Hydrocodone combination products are the most abused painkiller in the U.S. because they have addictive properties, are commonly prescribed and are easily available opioid analgesics.
Millions of Americans are believed to be using potent painkillers without prescription and without really needing them. For those who are addicted to such drugs, treatment also comes in the form of another drug like Naltrexone.
Naltrexone was approved by the FDA in 1984 to treat opioid addiction and alcoholism in the mid-90′s. It has mainly been prescribed in oral or injection form until recently. Now, Naltrexone can be delivered in an implantable pellet form when compounded per a doctor’s prescription. The pellets are implanted under the skin for an effect that lasts for months.
The Naltrexone implant was developed by BioCorRx Inc. (BICX) to be used in its Start Fresh Program, which combines drug treatment and a life coaching that addresses the psycho-social aspects of the addiction. The implant, which is inserted by a doctor in an outpatient setting in less than 30 minutes, prevents relapse and helps with non-compliance of addicts, who typically don’t take medication as directed. Its effect is said to be immediate, with many patients reporting losing their cravings just hours after the procedure.
Once Naltrexone takes effect, patients are able to absorb the teachings of their coaches and counselors without the intrusive cravings distracting them from recovery. The one-on-one life coaching sessions can be done in Start Fresh clinics or through video conferencing for those living far from any of the centers. The entire program can last 6 to 8 months and can be done with complete privacy and with little or no time missed from work or family.
With the changing landscape of drug abuse, health solutions companies will continue to develop such innovative programs that will make recovery more attainable for patients.