Titan Pharmaceuticals Inc.’s implanted drug-delivery device helped people fight addiction to heroin and prescription painkillers better than a placebo, a company-funded study found.
The Titan product, shaped like an inch-long match-stick, is implanted under the skin and delivers continuously the drug buprenorphine. Patients implanted with the device showed they were free of illegal opiates in about 40 percent of urine tests in the first 16 weeks, compared with 28 percent of those getting the placebo implant. People on the drug had fewer withdrawal symptoms, according to research published today.
The experimental device, Probuphine, is designed to help addicts who either skip or forget to take doses of buprenorphine, a medicine that reduces craving for opioids and symptoms of withdrawal. The study represents the third of three phases of tests generally required for U.S. Food and Drug Administration approval. Titan plans to seek clearance of Probuphine in the U.S. and Europe.
“The implant is going to make a significant impact in the way people with opioid addiction can receive treatment,” said Katherine Beebe, senior vice president of clinical development and medical affairs for South San Francisco, California-based Titan. “It delivers a very low level of drugs and the side effects associated with the implant are tolerable.”
Buprenorphine is sold for the treatment of addiction to opiates, including the prescription painkiller OxyContin, under the brand names Suboxone and Subutex by Reckitt Benckiser Group Plc, based in Slough, U.K.
Another standard treatment for addiction to opiates is methadone.
Alkermes Inc. of Waltham, Massachusetts, has applied to the FDA to market its alcoholism drug, Vivitrol as a treatment for opiate addiction.
In today’s study, published in the Journal of the American Medical Association, Titan’s Probuphine was implanted under the arms of patients to deliver a continuous dose of the medicine for six months.
“Buprenorphine treatment by all accounts is a big success for treating opioid addiction,” said Walter Ling, the lead study author, who is a professor of psychiatry and director of the Integrated Substance Abuse Programs at the University of California, Los Angeles, in a telephone interview today. Ling reported receiving research support from Titan and Reckitt Benckiser.
Beebe declined to say when the company would seek FDA approval for Probuphine. Titan’s chief executive officer, Sunil Bhonsle, said today that the company is exploring its options, including the possibility of partnering to sell Probuphine. He declined to name any companies Titan has spoken with.
In the study, researchers included 163 adults ages 18 to 65 years who were diagnosed as dependent on opiates. Of those, 108 were given either four or five Probuphine implants and 55 received placebo implants. All participants were provided with drug counseling. Some patients in each group also received extra buprenorphine tablets to help with cravings and withdrawal symptoms during the study.
About 66 percent of patients given Probuphine completed the study compared with 31 percent of the placebo group.
For the duration of the six-month study, 37 percent of the urine samples in the Probuphine group tested negative compared with 22 percent in the placebo group.
“It’s very, very hard to get an addict to completely stop using the drug, particularly early in treatment,” Beebe said. She said many of the people in the study were just beginning treatment to fight their addiction, a challenge that can take months or years.