|Medtronic Begins Landmark Study of Neurostimulation Therapy; Repros Offers Update from First Pivotal Study of Androxal|
|By Staff and Wire Reports|
|Monday, 28 January 2013 20:18|
Medtronic, Inc. (NYSE: MDT) announced the start of PROMISE, a Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain. This is the first-ever, large-scale study comparing the effectiveness of Medtronic neurostimulation therapy with Specify® 5-6-5 multicolumn surgical leads plus optimal medical management (OMM) to the administration of OMM alone in patients with failed back surgery syndrome (FBSS) and predominant low back pain.
"Chronic pain is a clinically challenging and often debilitating condition for which oral medications may provide insufficient relief," said Bart Edmiston, M.D., principal investigator for the PROMISE study at The Neuroscience Center in Ocean Springs, Mississippi, which enrolled the study's first patient on January 8. "The PROMISE study will add to the growing body of evidence supporting Medtronic neurostimulation therapy, a well-established therapeutic approach, for the patients worldwide who continue to experience low back pain following back surgery."
It is estimated that more than 100 million U.S. adults1 and one in five European adults2 live with chronic pain. Back pain is the most prevalent type of chronic pain, affecting approximately 10 percent of the U.S. population alone.3 FBSS is defined as persistent or recurring pain in the back or legs following one or more spine surgeries. The majority of FBSS patients receive physical rehabilitation and/or oral medications to help manage their pain, but studies and clinical experience find that many of these patients will not sufficiently improve and will require additional interventions.4
Medtronic neurostimulation therapy (also known as spinal cord stimulation, or SCS) is a widely established treatment option for chronic back and/or leg pain that has been used to treat more than 250,000 people worldwide. It uses a medical device to deliver mild electrical impulses to the spinal cord to block pain signals from reaching the brain.
PROMISE is a prospective, randomized, open-label, parallel-group, clinical study enrolling up to 300 individuals suffering from predominant chronic low back pain due to FBSS at 30 centers in the United States , Canada and Europe (Belgium, France, Germany, Spain, The Netherlands and The United Kingdom). It is the first large-scale, randomized, controlled clinical trial designed to assess the value of SCS for predominant low back pain with leg pain using a surgical lead, in contrast to previous studies of this technology, which have focused on predominant leg pain.
"Spinal cord stimulation has become an increasingly valued treatment approach in chronic pain, and we look forward to participating in the latest study," said Philippe Rigoard, M.D., the study's global principal investigator, who started enrolling patients January 14 at Poitiers University Hospital in Poitiers, France. "If the PROMISE results are positive, they will provide critically needed relief for those patients suffering from chronic low back pain associated with FBSS."
PROMISE participants will be randomized 1:1 to receive treatment with either SCS with OMM or OMM only. After a six-month observational phase, the study will compare the proportion of participants in the SCS group who report more than 50 percent reduction in low back-pain intensity, as measured by the Numeric Pain Rating Scale, with those in the OMM-only group. Health care utilization data collected will be used to develop cost analysis models for potential use in future studies evaluating the long-term economic impact of SCS.
"Medtronic is committed to advancing the understanding of its neurostimulation therapy in patients with low back pain resulting from FBSS," said Julie Foster, general manager and vice president, Pain Stimulation and Targeted Drug Delivery in the Neuromodulation business of Medtronic, Inc. "PROMISE provides the opportunity to assess not only the degree of pain relief provided by SCS plus OMM compared to OMM alone in failed back surgery patients, but also to evaluate the economic and quality of life impact of this treatment by looking at such important measures as sleep, ability to work and changes in pain medication."
Repros Therapeutics Inc.® (Nasdaq: RPRX) earlier provided a revised date for expected clinical results from the first pivotal study, ZA-301, of Androxal® in the treatment of secondary hypogonadism. The Company now plans to provide the data in Q3 2013 instead of Q2 2013.
During the ongoing review of the data it was determined that one site's patient population was markedly different from the other 16 sites from the standpoint of baseline sperm counts. The site in question had enrolled 40 subjects into the 151 subject trial. Though the subjects at the site meet the strict entry criteria for the trial, the clear difference from the other sites begs the question of whether or not this site represents the general population to be treated or is, in fact, a special population. To that end, the Company felt it would be prudent to remove the site from the efficacy studies and replace the subjects with those enrolled at other sites. Preliminary blinded analysis of reported subjects from the identified site indicates these subjects have responded as well or better than the other sites from the standpoints of improved testosterone and maintenance of sperm concentration.
Fortunately, the Company is enrolling subjects into the identical pivotal trial ZA-302. The current plan, pending regulatory approval, is to move already enrolled subjects from sites in ZA-302 to ZA-301 to make up the shortfall. Since many of these subjects have recently been enrolled, it will extend the time before the data base from the first study can be locked and analyzed. The Company believes it can have the data available for top line release in Q3 of this year.
The Company is attempting to schedule a meeting with the FDA to advise the Agency of Repros' plan. Repros believes this outcome will not affect the timing of the NDA submission currently targeted for mid-2014.
Conference Call Details: Time: Monday, January 28, 2013 – 8AM Eastern Participant Dial In Number: 877-407-0782 International callers: 201-689-8567 Participant Title: Repros Therapeutics Teleconference Replay will be available until February 4, 2013. Replay Number: 877-660-6853, Conference ID#: 408375
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