Titan Pharmaceuticals Inc. today released positive results from its phase 3 clinical study of Probuphine™ to evaluate the safety and efficacy of the drug in treating patients with opioid dependence. The drug was developed using Titan’s continuous drug delivery system ProNeura.
The company reported statistically significant results from the study, which confirmed the efficacy of Probuphine compared to placebo. Probuphine also met a key trial objective by demonstrating non-inferiority to treatment with the approved drug Suboxone®. In addition, the trial demonstrated that Probuphine was well tolerated, with an overall safety profile similar to previous study results.
Based on the results, Titan said it plans to request a meeting with the U.S. Food and Drug Administration (FDA) this fall to review the Probuphine development plan and for filing a New Drug Application.
“We are highly encouraged by these compelling findings, which confirm the positive results from our previously reported, placebo-controlled study, and believe that Probuphine represents an important medical advance in the effective treatment of patients suffering from opioid addiction,” Katherine L. Beebe, Ph.D., principal investigator for the study, and executive vice president and chief development officer of Titan stated in the press release. “We look forward to continuing our ongoing dialogue with regulatory authorities to efficiently advance Probuphine toward approval and also to progressing discussions with potential commercialization business partners.”
Lead investigator in the study, Walter Ling, M.D., is also professor of psychiatry and director of Integrated Substance Abuse Programs at the David Geffen School of Medicine at UCLA. Dr. Ling expressed the deep need for treatment to combat but also noted ongoing concerns in the clinical community.
“While buprenorphine has made a dramatic impact in the clinical treatment of opioid addiction, there is still a concern among physicians about compliance and diversion and the potential for abuse with the sublingual formulations of the drug,” Dr. Ling stated. “Probuphine has again shown the potential to alleviate those concerns while providing patients with a consistent and effective dose of buprenorphine. These findings are extremely important to the clinical community as opioid addiction is an undeniable — and growing — healthcare issue and there is a critical need for safe and effective treatments that offer patients relief without serious concerns of diversion and potential for abuse.”
For more information visit www.titanpharm.com