New Drugs for Pain, New Profits from Pain

Three Upcoming Pain Drugs – Clinical Pain Advisor – January 25, 2017 – Laura Stiles, Assistant Editor

Due to the prevalence of prescription opioid abuse in the United States, the development of abuse-resistant pain medications has been a focus for many pharmaceutical companies in recent years.

Pharmaceutical companies are poised to take advantage of new government-supported requirement that opioids be abuse-resistant because this will allow them to develop new patentable and profitable drugs.

For many of us, the older opioids we take do NOT generate much profit for these companies, so our campaign to have access to our existing opioids is not in the best interest of drug companies.

Kolodny’s latest accusation that patients are merely an opioid lobbying group is thus absurd.

We examine 3 alternative medications  currently in development for the treatment of postoperative and chronic pain.

  1. ARYMO™ ER (morphine sulfate) extended-release (ER) tablets C-II

The Egalet Corporation received FDA approval in January 2017 for an extended-release morphine sulfate tablet (ARYMO ER) for the treatment of chronic pain. This tablet has been designed to resist “cutting, crushing, grinding, or breaking.” Because the tablets turn into a viscous hydrogel when in contact with liquid, they cannot easily be turned into an injectable form. The tablets are available in 15-mg, 30-mg, and 60-mg doses.

This seems rather pointless since morphine tablets are rarely abused compared to other opioids, like hydrocodone (Vicodin, Norco) or oxycodone (OxyContin).

  1. ARX-04, known as DSUVIA™ (sufentanil sublingual tablet, 30 µg)

This is not a new drug, just a new method of delivery.

Sufentanil is a synthetic opioid analgesic drug approximately five to 10 times more potent than its parent drug, fentanyl, and 500 times as potent as morphine.

AcelRx Pharmaceuticals, Inc, has submitted a New Drug Application to the FDA for DSUVIA, a sublingual tablet administered using a single-dose applicator in the treatment of moderate to severe acute pain.

This drug is meant to be an alternative to intravenous opioids in postoperative settings and emergency departments.

In September 2016, AcelRx completed 3 phase 3 trials (SAP301, 302, and 303) that comprise the ARX-04 phase 3 clinical program. SAP301 showed that over the first 12 hours of treatment patients receiving ARX-04 had significantly more pain relief than patients in the placebo group; SAP302 compared a single dose of ARX-04 with multiple doses as needed; and SAP303 measured improvements in pain intensity in 140 patients.

It’s wonderful that a powerful and long-lasting pain drug is being developed that can be taken orally instead of intravenously.

Unfortunately, this is NOT for chronic pain patients, just acute.

  1. Combined bupivacaine and anti-inflammatory meloxicam: a local anesthetic after abdominoplasty

Heron Therapeutics has announced results from its phase 2 trial of HTX-011 for postoperative pain. The locally administered HTX-011 combines the local anesthetic bupivacaine with the anti-inflammatory meloxicam into a single-administration local anesthetic that is meant to reduce or eliminate the need for opioids following abdominoplasty. This is the first long-acting anesthetic designed to address both postoperative pain and inflammation in this way.

There is nothing new about this medication because it is just a combination of two currently existing drugs.

Results from the phase 2 clinical study showed that HTX-011 produced a statistically significant reduction in pain 96 hours after surgery (36.6%, P =.0104).

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