June 2011: Research Roundup

Army Plans Study of Fast-onset Product for Acute Pain from Trauma or Injury

The US Army Medical Research and Material Command (http://hcp.lv/m6Ifnq) will work with AcelRx Pharmaceuticals, Inc () to develop ARX-04, a “non-invasive, fast-onset sublingual product for the treatment of moderate-to-severe acute pain.” This product will deliver the high therapeutic index opioid sufentanil using AcelRx’s NanoTab® technology, ensuring rapid-onset analgesia and “a consistent pharmacokinetic profile due to a high percentage of drug being absorbed sublingually instead of through the gastrointestinal tract.” It is intended to be used for patients in acute pain, “both on the battlefield and in civilian settings of trauma or injury.” The company intends to initiate a phase II study later in 2011 to evaluate two dosing options.

http://hcp.lv/mP3rHb

Positive Results Expected Soon for Subcutaneous Buprenorphine Option

Titan Pharmaceuticals, Inc, is expected later this month to announce favorable results from a phase III study involving Probuphine, the company’s experimental implantable buprenorphine product for the treatment of opioid addiction. This formulation is designed to deliver a steady, continuous dose of buprenorphine over a six-month period following an in-office implantation procedure. Data from a previous study were published in JAMA in 2010 (http://hcp.lv/kMV8YL), with the authors reporting that “in persons with opioid dependence, the use of buprenorphine implants compared with placebo resulted in less opioid use over 16 weeks as assessed by urine samples.” The study also showed that patients who received the Probuphine implant “had significantly less illicit opioid use, experienced fewer symptoms of withdrawal and craving, stayed in treatment longer and had greater overall improvement when compared to placebo patients over the course of the sixmonth study” (http://hcp.lv/kkkA7l). Some analysts are predicting that positive results from the latest study will “[set] the stage for a pre-NDA meeting with the FDA to review clinical and other support data late in the third quarter 2011,” putting the company “on track to file an NDA in the first quarter 2012,” with a commercially available product by 2013.

http://hcp.lv/mPnT0i

Novel Gene Therapy Shows Promise for Treating Intractable Pain Associated with Cancer

Researchers from the University of Michigan Department of Neurology rhttp://hcp.lv/kGFtGmecently reported positive results from a small trial in which 10 patients “with unrelenting pain caused by cancer” received injections of the gene transfer vector NP2, which expresses the naturallyoccurring opioid peptide enkephalin. One of the study’s authors reported that although patients who received a low dose of vector “showed little reduction in pain,” patients injected with a higher dose “showed a greater than 80% reduction in pain over the course of four weeks following treatment.” Preliminary results published in the Annals of Neurology (http://hcp.lv/lhvchi) showed the treatment was well tolerated “with no study agentrelated serious adverse events (SAE) observed at any point in the study.” A clinical trial (http://hcp.lv/kQkoA0) to “examine the impact of intradermal delivery of NP2 on pain scores and pain medication usage in subjects with intractable pain due to malignant disease” is currently recruiting participants.

http://hcp.lv/kJ3Lde

The latest pain management studies on ClinicalTrials.gov

Assessing the Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets Compared to Placebo in Opioidexperienced Subjects with Moderate to Severe Pain Due to Chronic Low Back Pain Who Require Around-the-clock Opioid Therapy

Purdue Pharma LP is sponsoring this study, which will compare oxycodone/naloxone controlledrelease tablets to placebo in terms of “average pain over the last 24 hours” during week 12 of the study. Researchers will also monitor this product’s potential to cause sleep disturbance in patients.

http://hcp.lv/m5EGKH

Sativex for Relieving Persistent Pain in Patients with Advanced Cancer (SPRAY III)

Otsuka and GW Pharmaceuticals, Ltd, are sponsoring a trial that will compare the efficacy, safety and tolerability of Sativex oralmucosal spray vs. placebo in patients with late-stage cancer who are experiencing persistent uncontrolled chronic pain refractory to standard treatment.

http://hcp.lv/kGFtGm

Long-term Safety and Tolerability of Novel Treatment for Opioid-induced Constipation in Patients with Non-cancer-related Pain

This phase III study will evaluate AstraZeneca’s NKTR-118 and compare it to standard care in terms of the incidence, nature, and severity of adverse and serious adverse events.

http://hcp.lv/lojU02