Innovation: A sublingual pill for post-surgical pain

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In this occasional series, PR looks at companies, organizations, and individuals doing groundbreaking work that aims to help pain patients “live more, hurt less.”

By Lorie A. Parch

BloombergBusinessWeek recently reported that shares of specialty drugmaker AcelRx Pharmaceuticals had hit an all-time high once Wall Street heard that the company was on track in its development of a new method for delivering the painkiller sufentanil citrate. A large number of post-surgical patients may be helped by AcelRx’s proprietary NanoTab system, which should be under consideration for approval by the Food and Drug Administration later this year. According to MedlinePlus, part of the National Institutes of Health, more than 15 million Americans have surgery every year. It probably goes without say that many, if not post, experience big-time post-operative pain. One 2003 study reported that 86 percent of post-op patients had moderate, severe, or extreme pain, much of it experienced after they had gone home from the hospital.

AcelRx’s website states that with NanoTab, patients take a tiny pill under the tongue for acute and “breakthrough” pain (which occurs for short periods and is not controlled by a patient’s normal medications). Currently, the active ingredient in NanoTab sufentanil, an opioid analgesic is administered post-surgically via an IV or epidural, according to MedlinePlus.

NanoTab has been tested in people who just had hip or knee replacement, or abdominal surgery, and compared with a placebo. (Every year, more than 1 million patients have hip or knee replacements, according to the Centers for Disease Control.) In the clinical trials, researchers found that NanoTab, or sublingual sufentanil, delivers fast and consistent relief with fewer side effects than the IV-delivered drug. If approved, NanoTab would allow patients to take medication when they needed it to manage pain, giving them more options and reduced odds for infection.

The Agency for Healthcare Quality and Research, part of the Department of Health and Human Services, calls opioids “the first-line treatment for severe acute post-operative pain” and says the “most effective mode is patient-controlled analgesia (PCA).” NanoTab combines those two features, so if it’s approved it would give patients another and much less invasive way to control pain.

Pain Resource will watch and report if NanoTab gets FDA approval. AcelRx plans to submit a new drug application later this year.

If you’ve had surgery, was your post-operative pain medication effective? Would you be interested in a pill you could place under your tongue to control post-op pain? Please join our community to discuss.

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