Pain Management Drug and Device Research and Approval News

From bench to bedside: News and notes on pain medicine studies and research announcements from around the world.

The FDA denied approval for the drug, being co-developed by Pfizer and Pain Therapeutics, Inc, based on concerns over “inconsistent release performance” during testing, among other problems cites in the complete response letter it sent to the companies. An article published on website of the Austin American-Statesman (Pain Therapeutics is based in Austin, TX) noted that it is not clear yet whether the inconsistencies flagged by the FDA were the result of problems with the manufacturing process or with the tests themselves. It is not known at this point how long this latest setback will delay approval of Remoxy.

Short-acting Oxecta Approved for the Management of Acute and Chronic Moderate to Severe Pain, but Company Must Perform Additional Research to Demonstrate the Abuse-deterrent Potential

The FDA in June approved the drug Oxecta, a new formulation of oxycodone hydrochloride, for the management of acute and chronic moderate to severe pain. Made by Pfizer using Acura Pharmaceuticals’ “Aversion Technology” that provides “abuse deterrent features and benefits for orally administered pharmaceutical drug products,” Oxecta is an immediate-release oxycodone formulation. Opioid-naïve patients should be started on this medication at 5 to 15 mg every four to six hours as needed for pain. Oxecta is contraindicated in patients with respiratory depression, paralytic ileus, and acute or severe bronchial asthma or hypercarbia. It should be used with caution in patients with head injuries or other intracranial lesions, severe renal or hepatic impairment, Addison’s disease, hypothyroidism, prostatic hypertrophy, urethral stricture, or mental impairments.

St. Jude Medical Inc Releases Favorable Study Results for Its Peripheral Occipital Nerve Stimulator for Chronic Migraine

In the study, 157 patients who suffered from an average of 26 headache days per month were randomized to 12 weeks of treatment with either placebo or the Genesis neurostimulator. Patients were followed for one year. Patients in the active treatment group reported a 28% decrease in their number of headache days (seven less days a month) compared to the placebo group. Patients also reported significant improvements in their pain as expressed by scores on the Zung Pain and Disability Index and MIDAS scales.

Latest Clinical Trials

Tiny Trial to Evaluate the Effectiveness of Acupuncture in Reducing the Signs of Inflammation in Patients with Chronic Low Back Pain

This National Center for Complementary and Alternative Medicine trial will “investigate the effect of acupuncture on [low back pain] by measuring serum cytokine and hormone levels before and after treatment in participants.” Investigators will also test histone modification and methylation patterns of CpG islands on the promoters of selected genes in the peripheral CD4(plus) T cells to “define the molecular mechanism by which acupuncture affects [low back pain].

Phase III Study of NKTR-118 for Treatment of Opioid-induced Constipation in Patients with Cancer-related Pain

AstraZeneca will soon begin recruiting more than 300 patients for participation in this trial to “compare the effect of NKTR-118 with placebo in the treatment of opioid-induced constipation (OIC) in patients with cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).” Primary outcome measures will include response to the study drug, defined as “having at least 3 Rescue-free bowel movements (RFBMs) per week during the 4-week treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks.” Patients who are receiving treatment with opioid medications for non-cancer pain are ineligible for this trial.

Group-based Intervention Using Cognitive Behavioral Therapy for Pain and Substance Use Disorders

The National Institute on Drug Abuse and the University of Michigan will enroll more than 450 participants from a large residential substance abuse disorder (SUD) treatment program and randomize them to either a four-week (eight sessions) regimen of integrated cognitive behavioral therapy (CBT) for pain and SUDs or a four-week (eight sessions) “Supportive Psychoeducation Control” group. Establishing the effectiveness of this CBT program could “significantly extend available treatment options for the large numbers of patients with pain seen by SUD treatment providers.” This may prove especially significant because supplementing pharmacological treatment with CBT in the SUD setting may help reduce the risk for “the potential for abuse and diversion of opiate medications by patients in SUD treatment.” There is also “recent evidence that untreated pain may undermine the effectiveness of standard treatments for SUDs.”