Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Titan Pharmaceuticals Announces Positive Results of Six-Month Open-Label Safety Retreatment Study of Probuphine

Published: Thursday, February 09, 2012
Last Updated: Thursday, February 09, 2012
Bookmark and Share
Patients report high satisfaction, decreased opioid dependence problems and significant overall improvement with Probuphine; NDA expected to be filed in 3Q 2012.

The company announced the results of an open-label, six-month safety re-treatment study (PRO-811) of patients with opioid dependence who previously completed a full six months of treatment in Titan's confirmatory Phase 3 clinical trial of the investigational drug Probuphine™. In the 85 patients enrolled in this retreatment study, Probuphine was shown to be well tolerated, including the implant insertion and removal procedures, with a low incidence of adverse events and overall safety profile similar to that observed in the confirmatory Phase 3 study. Patients also reported a decreased use of illicit opioids, good control of opioid withdrawal and cravings and high overall satisfaction with Probuphine. These data build upon the positive results of the Probuphine Phase 3 program reported to date and further support the company's preparation of a New Drug Application (NDA) for Probuphine.

Titan also provided an update on the preparation of the NDA for Probuphine, which it now plans to submit in the third quarter of this year. The company is on track to complete its analytical testing of Probuphine to provide additional Chemistry, Manufacturing and Control (CMC) data requested by the U.S. Food and Drug Administration (FDA) along with its preparation of the integrated clinical data, summary reports and electronic document preparation by mid-year. The manufacturing facility expansion and qualification for commercial scale production of Probuphine is in process, but has been slightly delayed due to longer than expected lead-time on air handling equipment and the manufacturing of three qualification batches is now expected to be completed in September.

"As a clinician, I know first-hand how desperate the patient need is for a safe and effective treatment for opioid dependence, especially one that patients feel improves their condition and their compliance," said Walter Ling, M.D., Professor of Psychiatry and Director, Integrated Substance Abuse Programs at the David Geffen School of Medicine at UCLA. "These data continue to show that Probuphine could represent a new and potentially improved method of delivering buprenorphine to patients -- one that improves the quality of life of patients, lessens physicians' concerns about compliance and medication diversion and shifts the treatment landscape."


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,500+ scientific posters on ePosters
  • More than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
NIH Launches Human RSV Study
Study aims to understand infection in healthy adults to aid development of RSV medicines, vaccines.
Computerized Flexible Needles Prove Themselves in Biological Tissue
The advantage of the system is that you can avoid obstacles with the needles or critical tissues and that the system during the insertion of the needle in real time can adjust the path if, for example, the tissue deforms.
DARWIN 2 24-week Monotherapy Data in RA Confirm Previous Results
Safety profile in DARWIN 2 consistent with previous filgotinib RA studies.
Researchers Publish Landmark “Basket Study”
Researchers from Memorial Sloan Kettering Cancer Center (MSK) have announced results from the first published basket study, a new form of clinical trial design that explores responses to drugs based on the specific mutations in patients’ tumors rather than where their cancer originated.
Agricultural Intervention Improves HIV Outcomes
A multifaceted farming intervention can reduce food insecurity while improving HIV outcomes in patients in Kenya, according to a randomized, controlled trial led by researchers at UC San Francisco.
Overdose of Vitamin D in Teenagers May Lead to Increased Cholesterol Levels
Dosing obese teens with vitamin D shows no benefits for their heart health or diabetes risk, and could have the unintended consequences of increasing cholesterol and fat-storing triglycerides. These are the latest findings in a series of Mayo Clinic studies in childhood obesity.
Phase 2 Trials Underway for New Single Dose Malaria Treatment
The new drug, which prevents the malaria parasite from reproducing and spreading, is now undergoing Phase II clinical trials in humans.
Promising Drug for Parkinson's Disease
A drug which has already been in use for decades to treat liver disease could be an effective treatment to slow down progression of Parkinson’s disease, scientists from the University of Sheffield have discovered.
Benefits of Early Antiretroviral Therapy in HIV Infection
Scientists have explored the clinical importance of starting treatment early in individuals suffering with HIV.
Scroll Up
Scroll Down
SELECTBIO

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!