Wednesday, May 1, 2013

May 2013 – Pain Product Announcements & Warnings

Pain Product AnnouncementsFeatured Items: lubiprostone (Amitiza) approved for treating opioid-induced constipation; controlled-release oxycodone HCl (OxyContin) abuse-deterrent labeling approved; generic versions of Suboxone (buprenorphine/naloxone) receive FDA approvals. — All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Lubiprostone (Amitiza®) – FDA Approved for Opioid-Induced Constipation
Takeda Pharmaceuticals and Sucampo Pharmaceuticals announced an April 2013 U.S. Food and Drug Administration approval of Amitiza for opioid-induced constipation. Amitiza had already been approved in 2006 to treat adult chronic idiopathic constipation and in 2008 for irritable bowel syndrome with constipation in adult women. The supplemental NDA received a priority review because lubiprostone is the first oral treatment for opioid-induced constipation.

This approval was based on results from a long-term open-label safety study and 12-week phase 3 studies in adult patients prescribed full-agonist opioids — including morphine, oxycodone, and fentanyl — for chronic noncancer pain. Results in 2 of 3 placebo-controlled phase 3 trials showed that significantly more patients taking 24 mcg lubiprostone twice daily achieved the established primary endpoint of 3 or more spontaneous bowel movements per week for 9 weeks or more. Patients in the lubiprostone group also reported a significantly reduced median time to first spontaneous bowel movement. The efficacy of lubiprostone in patients taking diphenylheptane opioids like methadone has not been established.

Common adverse effects reported by patients taking Amitiza in clinical trials were diarrhea or nausea and patients are encouraged to inform their healthcare provider if these reactions occur. Lubiprostone should be prescribed cautiously in pregnant women and patients with symptoms or suspicions of gastrointestinal obstruction should not take lubiprostone. For full administration and safety instructions, read the Amitiza prescribing information PDF.

Controlled-Release Oxycodone HCl (OxyContin®) – Abuse-Deterrent Labeling Approved
Purdue Pharma announced an April 2013 FDA approval of an updated OxyContin label that acknowledges abuse-deterrent properties for this product that was reformulated in August 2010. The new formulation has physical and chemical properties that are expected to reduce abuse by injection or intranasal use. It is also possible that there will be a reduction in misuse due to reformulation characteristics that could resist crushing or dissolving. Because the FDA has determined that the risks of using the original version of OxyContin are greater than the benefits, the agency announced that the original formulation must be withdrawn from sale, and new drug applications for generic versions of controlled-release oxycodone without abuse-deterrent features will not be accepted by the agency. See the FDA News Release and OxyContin prescribing information PDF for further details.

Generic buprenorphine/naloxone – Two Makers Receive FDA Approval
Generic drug makers Amneal Pharmaceuticals and Actavis Elizabeth each reported a February 2013 FDA approval of their combination buprenorphine HCl and naloxone HCl dihydrate sublingual tablet, a product that is bioequivalent to Suboxone®. These are the first approvals for generic Suboxone, a once-daily opioid therapy that is indicated for the maintenance treatment of opioid dependence (ie, addiction). The orange-flavored combination tablets are available in 2 mg/0.5 mg and 8 mg/2 mg strengths, packaged in 30-count bottles. Healthcare providers and patients are reminded that buprenorphine HCl with naloxone HCl dihydrate can cause severe, even fatal, respiratory depression in children. Reports of severe respiratory depression and death have occurred in adult patients who have used buprenorphine intravenously in combination with CNS depressants, including alcohol and benzodiazepines.

Under the U.S. Drug Addiction Treatment Act (DATA), prescription use of this product in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription. For complete administration and safety information, see the Amneal Prescribing Guide PDF for buprenorphine HCl and naloxone HCl dihydrate sublingual tablets.

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