FDA Prioritizes Review of 'Abuse-Deterrent' Painkiller

Purdue Pharma LP’s hydrocodone bitartrate tablet (HYD) is undergoing “priority review” by the Food and Drug Administration (FDA), the company recently announced.

Reports said the tablet, if approved, will be the first painkiller with an “abuse-deterrent formula.” Such a formula will make it harder for the drug to be crushed or liquefied so it may be snorted or injected by drug abusers.

Market Watch pointed out that the FDA only gives priority review to new drugs that propose significant and improvement to the safety and effectiveness of existing drugs.

"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, was quoted saying.

Todd Baumgartner, MD, MPH, 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.”

“It is also designed to deter misuse and abuse by various routes of administration,” he added.

Market Watch explained that hydrocodone combination products are commonly prescribed opioid analgesics. It is for this reason that they are also the most abused.

Because of the easy access to painkillers and the addictive properties of some prescription drugs, opioid dependence and abuse have become a worsening problem in the U.S.

Millions of Americans are believed to be using potent painkillers without prescription and without really needing them.

In addition to the search for abuse-deterrent drugs, anti-addiction drugs are continuously being developed.

Naltrexone, for example, which was approved by the FDA to treat opioid addiction in 1984 and alcoholism in the mid-90’s 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.

One such program that uses this long lasting form of Naltrexone was developed by BioCorRx Inc. (BICX, http://finance.yahoo.com/q?s=BICX). The program is dubbed the Start Fresh Program and includes the use of Naltrexone in a long lasting pellet form followed by the implementation of a life coaching program that addresses the psycho-social aspects of the addiction. The procedure, which usually takes under 30 minutes, is administered by independent physicians in an outpatient setting.  The effect is said to be immediate, with many patients reporting to lose 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, which can last 6-8 months, can be done with complete privacy 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.