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Implant to treat opioid addiction awaits FDA nod

Implant to treat opioid addiction awaits FDA nod

02-12 | CDAH Team

The United States is witnessing an opioid epidemic and researchers have been looking for newer ways to combat the menace. A pharmaceutical company recently developed an implant, which it says can help people get free from the clutches of opioid and heroin addiction. However, nearly a month after the Psychopharmacologic Drugs Advisory Committee recommended the Food and Drug Administration (FDA) to approve the implant, the federal health advisers have raised concerns over it.

According to a recent report by the Associated Press, the advisers to FDA have questioned the effectiveness of the device and safety in its use. The experimental implant was earlier rejected in 2012 by the FDA on the very grounds.

The probuphine implant was originally developed by Titan Pharmaceuticals and New Jersey-based Braeburn Pharmaceuticals has licensed the rights to sell it in the U.S. if it’s approved. According to the developers, the device will carry drug buprenorphine, which can help people give up addiction. The drug-oozing implant, the size of a matchstick, is intended to be a safer, more reliable approach to controlling cravings and withdrawal symptoms.

The implant releases buprenorphine continuously for six months and this process helps in keeping a check on craving for drugs, thus managing addiction and relapse. Buprenorphine is an opioid that appears to work by activating the receptors in the brain that respond to opiates like prescription pain medications or heroin.

FDA decision likely by February end

On February 9, the developers told the FDA panelists that its implant could help reduce cases of relapse among patients with a history of drug abuse, as many of them struggle to stick with their daily medication and thus face the risk of returning to drug misuse.

However, according to the report, the panelists questioned whether Braeburn’s studies accurately predict probuphine’s success and cited shortcomings in the company’s research. The regulator is scheduled to make a decision on the device by February 27.

Drug menace

According to the National Institute on Drug Abuse (NIDA), in 2013, an estimated 24.6 million Americans aged 12 or older — 9.4 percent of the population — had used an illicit drug in the past month. This number is up from 8.3 percent in 2002. NIDA says an estimated 17.3 million Americans (or 6.6 percent population) are dependent on illicit substances. In spite of the enormity of the situation, only 2.5 million get any treatment. As part of its war against drugs, the U.S. government spent $26 billion in 2015 on treatment, prevention and law enforcement.

Prescription drug abuse is another area which the country is trying to deal with. According to a 2015 report by the Centers for Disease Control and Prevention (CDC), opioid overdose deaths in the U.S. reached a record level in 2014 following an increase of 14 percent in a year. Opioids contributed 61 percent of the 47,055 total drug overdoses in the U.S. in 2014.

According to CDC, just half of all people who take any kind of medication actually follow the prescription. About 20 to 30 percent of people never fill their prescriptions and others just forget to use them or choose not to use them.

This is one of the reasons behind Braeburn’s implant. “If you make a mistake, because opioid dependence is so unforgiving as a disease, one mistake could kill you,” Braeburn CEO Behshad Sheldon was quoted as saying in a media report.

The Barack Obama administration is trying its best to check the growing problem of drug and opioid addiction. The government announced in October 2015 that it will work to give more access to drug treatment and more specialized doctors will be trained about opiate painkiller prescription. In his final address before the joint session of the Congress on January 12, the President did not forget to mention about an extra effort needed to tackle “growing opioid-abuse epidemic.”

Treatment of addiction

Addiction is a chronic disorder and a one-time treatment will not help in getting full recovery from addiction. The recovery process is also marked by various stages of relapses. Thus, treatment will entail different forms with varying degrees of intensity.

According to NIDA, drug addiction treatment can include medications, behavioral therapies, or a combination of both. At present, three main medications are used to deal with drug addiction – naltrexone, buprenorphine (which is approved already in a pill form), and methadone. Each carries its own baggage of problems.

Braeburn is looking forward to an injectable buprenorphine that can be taken weekly or monthly. Dr. Melinda Campopiano, a medical officer at the Substance Abuse and Mental Health Services Administration (SAMHSA), told the New York Times, “I would not want to create the expectation that you can just implant this and say, ‘Bye-bye’.”

Treatment and therapies are available to deal with the problem of addiction. A holistic approach toward the problem can help you sail through the recovery process. Call the Colorado Drug Addiction Helpline today at 866-218-7546 for expert guidance.

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