FDA Approves New Long Acting Painkiller

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new extended release opioid pain medication with abuse deterrent properties.

Egalet Corporation announced Monday that the FDA has approved Arymo ER – a long-acting version of morphine -- for the management of pain severe enough to require daily, around-the-clock opioid treatment. It comes in the form of a pill that is very difficult to crush or liquefy, methods used by abusers to speed the release of an opioid into the bloodstream.

"With the majority of ER opioids in easy to abuse forms, it is important that healthcare professionals have additional treatment options like Arymo ER that are resistant to different methods of manipulation using a variety of tools," Bob Radie, president and CEO of Egalet said in a news release.

“Arymo ER has physical and chemical properties expected to make abuse by injection difficult which is important given it is the most common non-oral route of morphine abuse and the most dangerous.”

An FDA advisory panel recommended in a 18-1 vote last August that Arymo be approved. It is is the 7th opioid with abuse deterrent properties approved by the FDA. The other medications are OxyContin, Targiniq, Embeda, Hysingla, Morphabond, and Xtampza.

Arymo has been approved in three dosage strengths: 15 mg, 30 mg and 60 mg. Egalet plans to make the drug available in the first quarter of 2017.

Arymo is the first commercial product developed with Egalet’s Guardian technology, which incorporates the medication into a polymer matrix tablet to make it difficult to misuse or abuse.

“Guardian Technology results in tablets that are extremely hard, very difficult to chew, resistant to particle size reduction, and inhibit/block attempts at chemical extraction of the active pharmaceutical ingredient,” the company says in a statement on its website.

“In addition, the technology results in a viscous hydrogel on contact with liquid, making syringe-ability very difficult. These features are important to address the risk of accidental misuse (e.g., chewing) in patients with chronic pain, as well as intentional abuse using more rigorous methods of manipulation. “

The approval of abuse-deterrent medications is still somewhat controversial. Some medical professionals and anti-opioid activists say the technology does not completely prevent abuse and the drugs are still being misused by addicts.

Half of Patients Have Trouble Getting Pain Meds

By Pat Anson, Editor

A new survey of chronic pain patients found that over half – 56 percent -- have experienced problems getting access to opioid pain medication, either from a pharmacy or their own doctor. Nearly half of the patients surveyed also said they have contemplated suicide.

“Access continues to be a problem and a growing problem for patients living with chronic pain,” said Jeff Dayno, MD, chief medical officer for Egalet, a pharmaceutical company that conducted the survey along with the American Chronic Pain Association (ACPA).

The online survey of over 1,000 patients was conducted in 2015, before guidelines were issued by the Centers for Disease Control and Prevention that discourage primary care physician from prescribing opioids for chronic pain. Although the guidelines are voluntary, they’ve had a chilling effect on many doctors and pharmacists since their release in March.  

“General practitioners who don’t have as much experience are having somewhat of a knee jerk reaction. Either they’re not prescribing opioids at all or taking a very cautious approach,” said Dayno.

“The broader medical community is backing away from the more effective type of pain medications and opioids specifically, even at the pharmacy level in terms of stocking them and having them available.”

Nearly two-thirds of patients (63%) said their pharmacy carries only a limited supply of pain medication. And nearly four out of ten patients (39%) said their physician no longer prescribes pain medication.

“Since the push to combat prescription medication abuse has risen, so have the number of calls we have received from individuals expressing their frustration about accessing their prescription medications,” said Penney Cowan, founder of the ACPA. “The study found that access really is an issue for individuals; they struggle to find doctors who are willing to treat them, and pharmacies that stock their medication.

“For individuals living with chronic pain, access to medication is vital to functioning in their everyday lives. Doctors would not withhold prescriptions from patients with other medical conditions such as diabetes or heart disease. What’s startling is the high percentage of individuals who have contemplated suicide.”

Forty-seven percent of the survey respondents said they’ve had thoughts of suicide.

“The statistic around patients contemplating suicide, we’ve seen numbers like that in the literature before. And that’s a very concerning and frightening aspect of the impact of limited access to effective pain medications,” said Dayno, who believes the number of patients complaining about access would be even higher if the survey was conducted today.

When asked by Pain News Network if he thought the CDC even considered suicides and other negative consequences on patients when it was drafting the guidelines, Dayno said no.

“I don’t think that dimension was clearly considered in the guidelines. I think it was much more of an evidence based, clinical approach on the pain management side. But the impact of potential barriers to access to these medications was not factored in to that assessment as part of the CDC guidelines,” he said.

A noted expert on pain management says he’s also seen “anecdotal reports” of primary care physicians and pain management specialists dumping pain patients since the CDC guidelines came out.

“I think some doctors are increasingly uncomfortable with continuing to prescribe what has been a higher dose of opioids, uncomfortable with the scrutiny that they’ve gotten, and as a consequence they are discharging patients from clinics, urging them to find care elsewhere,” said Sean Mackey, MD, Chief of the Division of Pain Medicine at Stanford University.