A look at pain management news and notes, August 2012.
As part of our continued effort to provide pain professionals with the resources they need, PainLive presents summaries of ongoing research and news in a broad range of pain management topics.
FDA Approves New Postherpetic Neuralgia Indication for Horizant
GlaxoSmithKline and XenoPort, Inc recently announced that the FDA has approved Horizant (gabapentin enacarbil) extendedrelease tablets for the management of postherpetic neuralgia (PHN) in adults. Originally approved in 2011 for the treatment of moderate-to-severe primary Restless Legs Syndrome in adults, the approval for the new indication of PHN was based on data from three clinical trials involving 574 adult patients from the US, Canada, and Germany.
Lyrica Receives New Indication for Treatment of Neuropathic Pain Associated with Spinal Cord Injury
According to a news release, Lyrica “received a priority review designation for this new indication” from the FDA, making Lyrica the first FDA-approved treatment for patients with neuropathic pain associated with spinal cord injury. Approval for the new indication was granted based on data from two phase III trials (one with patients who had suffered traumatic spinal cord injury, and one with a mix of patients who had suffered traumatic spinal cord injury and patients whose spinal cord injuries had non-traumatic causes). The release reported that “Lyrica significantly reduced neuropathic pain associated with spinal cord injury from baseline throughout the duration of the studies” compared to placebo. Also, “more patients receiving Lyrica showed a 30 percent and 50 percent reduction in pain than did patients receiving placebo.”
Study to Compare Sprix NSAID Nasal Spray to Oral Narcotics in Management of Acute Pain in the Emergency Setting
Emergency departments in 15 US hospitals will participate in the Acute Management of Pain from the Emergency Department (AMPED) study, which will compare the “efficacy, safety, economics, and patient satisfaction” of Sprix (ketorolac tromethamine) nasal spray and oral narcotics in patients who present to the emergency departments with acute moderate to moderately severe pain.
Food and Drug Administration Safety and Innovation Act Signed into Law without Proposed Hydrocodone Controls
The final version of the Food and Drug Administration Safety and Innovation Act signed into law on July 9 by President Obama did not contain an amendment proposed by US Senator Joe Manchin (D-WV) that would have reclassified hydrocodone products from Schedule III drugs to Schedule II (http://bit.ly/MnZer6). However, it has been reported that FDA advisors plan to meet in October “to discuss the risks and benefits of hydrocodone preparations used as pain relievers or cough suppressants.” According to a DEA spokesperson, if the FDA advisory group determines hydrocodone combination products require stricter oversight, the DEA will likely move to reclassify the products to Schedule II (http://bloom.bg/MKZxsA).
Positive Phase II Results for Acute Post-operative Pain Drug
Connecticut-based Cara Therapeutics Inc. recently reported positive phase II results for CR845, a drug intended for the treatment of acute post-operative pain. The primary endpoint of the study was “the effect of CR845 treatment on reducing the amount of rescue opioid analgesics used in the 24 hour period post-surgery.” In the study, patients treated with a pre- and postoperative dose of the novel, peptide-based, peripherally-acting kappa opioid agonist “exhibited a statistically significant reduction (~33%, p<0.05) of morphine use over 24 hours compared to the placebo group.” Patients also reported significant differences in 24-hour pain intensity with CR845 compared with placebo. The medication appeared to be safe and well tolerated, with fewer side effects commonly associated with opioid medications.
New Hampshire Becomes 49th State to Enact Prescription Drug Monitoring Program
New Hampshire Governor John Lynch recently signed into law a bill authorizing the state board of pharmacy to create a database that will allow physicians and pharmacists to track the distribution of prescription pain medications. The Nashua Telegraph reported that, under the new law, “information collected under the program would be deleted after six months, unless there was a suspicion of abuse, and police would need a court order to use the system” (http://bit.ly/ NW2pT1). According to The Concord Monitor, state pharmacists “will be required to report information each time they dispense the drugs, including the patient’s name, address and date of birth; the prescription number, quantity dispensed and number of refills; and the date the prescription was written, whether it was a refill and how the patient paid for it” (http://bit.ly/MuzQOr). Law enforcement agencies will need a court order to access the database, and physicians will be permitted to lookup information only for patients they are treating. Physicians and pharmacists will be required to register with the program before being granted access.
Massachusetts Insurer Plans to Restrict Amount of Pain Medications Physicians Can Prescribe
On July 1, Blue Cross Blue Shield of Massachusetts enacted measures that will restrict physicians’ ability to prescribe short-acting opioids for some patients. Physicians will be able to prescribe a 15-day supply of short-acting opioids, with one 15-day refill. To prescribe more to the patient, the physician must demonstrate to the insurer that he or she has taken several steps, including creating a treatment plan that includes patient education on the risks and benefits of opioids and other pain medications, conducting an assessment for addiction risk, and creating a written pain agreement.