Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

Regeneron and Teva Face FDA Hold On Chronic Pain Clinical Trial

XTALKS VITALS NEWS

FDA

The decision was made after a patient in the study developed severe joint inflammation.

Tweetables from this article:

Tweet: Pain drug – fasinumab – is being assessed as a possible treatment for chronic low back pain and #osteoarthritis pain http://ctt.ec/ctbzU+ Pain drug – fasinumab – is being assessed as a possible treatment for chronic low back pain and osteoarthritis pain.

Share this!

October 18, 2016 | by Sarah Hand, M.Sc.

Yesterday, Israel-based Teva Pharmaceuticals and their partner Regeneron, announced that the US Food and Drug Administration (FDA) has put their Phase IIb clinical trial for a chronic pain medication on hold. The decision was made after a patient in the study developed severe joint inflammation.

In addition to mandating the hold on the clinical trial, the FDA also called for a study protocol amendment. The pain drug – fasinumab – is being assessed as a possible treatment for chronic low back pain and osteoarthritis pain.

The setback prompted Regeneron and Teva to conduct an unplanned interim analysis of the study results, and all dosing was stopped. They found that at the eight and 12 week timepoints, the fasinumab group saw an improvement in pain scores.

“We are making data-driven decisions on Phase 3 fasinumab dosing that we believe will maximize potential benefit for patients in need, while minimizing the likelihood of side effects,” said Dr. George D. Yancopoulos, Chief Scientific Officer, Regeneron and President, Regeneron Laboratories. “We look forward to working with global health authorities to advance this important investigational therapy for patients with often difficult-to-treat osteoarthritis pain and chronic low back pain.”



Before receiving the clinical hold order, the clinical trial has enrolled around 70 percent of their 800 patient target. Study participants were assigned to one of three dosage groups, or a fourth placebo control group.

According to a press release issued by the companies, patients enrolled in the trial will be followed for up to 36 weeks. The patient who experienced the adverse event was participating in the high dose treatment arm.

“We believe fasinumab represents an important potential innovation for patients with osteoarthritis pain and chronic low back pain who currently have clear unmet need and limited treatment options,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva. “"We look forward to advancing clinical development for this promising novel therapy.”

Based on positive results of a previous Phase 2/3 clinical trial of fasinumab, Teva and Regeneron plan to push the lower doses of the drug into further trials, which will be subject to FDA approval. Both companies are collaborating on the global development and commercialization of the investigational chronic pain drug.


Keywords: FDA, Clinical Trial, Chronic Pain


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
Researchers Identify Role of ApoE4 Gene as Possible Drug Target in Alzheimer’s Disease

September 21, 2017 - A team of neurology researchers at Washington University School of Medicine in St. Louis have found that in the presence of the ApoE4 protein, another protein known as tau forms tangles in the brain which contributes to neuronal damage characteristic of Alzheimer’s disease.

Featured In: Life Science News


New Guidelines Address CAR-T Immunotherapy Toxicities to Prevent Patient Deaths

September 20, 2017 - Clinicians at The University of Texas MD Anderson Cancer Center have published new guidelines in the journal, Nature Reviews Clinical Oncology, which could help in the management of these toxicities.

Featured In: Biotech News, Drug Safety News


Microneedle Skin Patch Could Treat Common Metabolic Disorders

September 19, 2017 - Researchers at Columbia University Medical Center (CUMC) and the University of North Carolina have developed a microneedle skin patch impregnated with a drug capable of converting white fat into calorie-burning brown fat.

Featured In: Medical Device News


LEAVE A COMMENT
 
  
THE XTALKS VITALS INDUSTRY BLOG

Five Reasons Why Toronto is Emerging as a Major Life Sciences Hub

REGISTER FOR THESE WEBINARS

Development and Manufacture of Highly Potent API Drug Products Throughout the Clinical Phases


Innovation through Integration – Providing Next Generation Biomedical Devices and Interconnects


Clinical Payments Case Studies: Improving Efficiency, Cash Management, and Compliance


Why Phase 3 Trials Fail: Oncology Case Studies and Lessons Learned


Copyright © 2016-2017 Honeycomb Worldwide Inc.