The Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) has recommended the approval of a new treatment for opioid addiction by Titan Pharmaceuticals, called Probuphine, the company has announced.
The San-Francisco-based pharmaceutical company said that the approval decision was taken with a majority of 10 votes in favor, four negative votes and one abstention at the PDAC meeting in Silver Spring, Md. The recommendation for approval was based on Probuphine's safety, effectiveness and risk-benefit profile shown in clinical studies, Titan said.
According to the manufacturer, Probuphine is a long-acting, subdermal implant formulation of buprenorphine for the maintenance treatment of adult patients with opioid dependence. Panel member Dr. Louis Baxter commented that it was a drug that the public needed and any opportunity to improve treatment of opioid dependence should be embraced if it is safe enough for patients, Reuters reported.
Even though the FDA is not obliged to follow its advisors' recommendations, it usually takes into account their opinion. In this particular case, considerations against approving the treatment include concerns that Titan may not be prepared with an adequate plan for the marketing of the drug, considering the potential abuse of similar drugs. Probuphine is implanted under the skin of the upper arm by general practitioners and some of the FDA advisors were concerned that lack of surgical skills may prevent effective treatment.
However, another member of the committee, Dr. Christopher Kratochvil, said that there were implant materials on the market that the FDA and the public trust, referring to the progestin-releasing contraceptive Norplant, which is also implanted under the skin. PDAC chairman Dr. Edward Covington summarized the meeting by stating that the panel agreed Titan's drug had a great potential but questions remained regarding the right dose and an effective plan for risk mitigation when the drug is launched.
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Despite these concerns, Titan accepted the decision as a victory. Kate Glassman-Beebe, executive vice president and chief development officer of the company, stated that Titan was happy with the support Probuphine received. The PDAC recognized the favorable benefit-risk profile of the drug and therefore voted convincingly in favor of the treatment, she added. Titan looks forward to working in cooperation with the FDA on the complete review of Probuphine and would continue to work with commitment to meet the needs of patients with opioid dependence, the company said.
Recent figures revealed that there are about 2.2 million people with opioid dependence in the United States, with one in five of those addicted to illicit opioids, such as heroin. The remaining 80 percent are addicted to prescribed opioids, such as oxycodone, hydrocodone, methadone, hydromorphone and codeine. Overall, the number of people who die of drug overdose has tripled in two decades. In 2008 alone more than 36,000 people died from an overdose, mostly caused by opioid painkillers.