Market for overdose fixes tied up as epidemic rages: analyst

Print 30 September 2016
Randy Osborne / BioWorld

Prescription Opioid and Heroin Epidemic Awareness Week closed Friday, but intense talks around the topic and related drug development haven't stopped – and probably won't anytime soon.

The House of Representatives Judiciary Committee convened to discuss the problem in a session titled "Treating the Opioid Epidemic: The State of Competition in the Markets for Addiction Medicine," including testimony by such heavyweights as Anne Pritchett, vice president of policy and research for the Pharmaceutical Research and Manufacturers of America (PhRMA). She cited figures from the Centers for Disease Control and Prevention, which found the rate of deaths from drug overdoses has increased 137 percent, including a 200 percent rise in the rate of overdose deaths involving opioids (opioid pain relievers and heroin) since 2000. Related to the abuse of prescription opioids, the economic burden is estimated as high as $78.5 billion, when tallying health care, substance abuse treatment and criminal justice costs. She said the country "must collectively redouble our efforts to prevent the misuse, abuse and diversion of prescription medicines," adding that, while more than 90 percent of the prescription medicines most susceptible to abuse are generic, PhRMA and its members are committed to supporting the "appropriate use of prescription medicines."

Specifically, Pritchett said public policy needs to require ongoing prescriber education and training to ensure appropriate prescribing of controlled substances, effective pain management and identification of patients at risk for prescription drug abuse and overdose, as well as those in need of treatment. Awareness of available treatment options should broaden, she said. Policy also ought to foster the development and dissemination of evidence-based clinical guidelines to inform opioid selection, dosage, duration, follow-up and discontinuation. Guidance on the first opioid prescription for patients in acute pain is key to ensure that no greater quantity than needed is prescribed for the expected duration of pain severe enough to need opioids, she said.

Doctor-shopping is a problem, too, Pritchett said. "One of the most promising tools in preventing and detecting potential doctor shoppers while allowing for legitimate medical use of needed prescription medicines by patients is Prescription Drug Monitoring Programs," she said. These are state-run databases that collect, analyze and share dispensing information on controlled substances, providing critical information to providers to inform their prescribing.

Abuse-deterrent formulations are important, Pritchett said, along with clarity about laws so that enforcement personnel have adequate leverage in shutting down "pill mills," and patients need expanded treatment capacity, coverage and access. Treatment approaches "must be individualized to address each patient's particular circumstances and any other medical, psychiatric and social problems," she said, noting that, "while many patients relapse that does not mean treatment failed. Rather, it suggests that the treatment plan needs to be reevaluated." The nature of addiction "underscores the importance of having multiple treatment options that can be tailored to prescriber and patient needs," she added.

GENERIC INJECTABLE MAY BE AHEAD

Pending the changes, opioid overdose – including fentanyl and heroin – remains a big problem, with fatal outbreaks recently in Milwaukee; Surrey, British Columbia; south Florida; and parts of Maryland. But they can happen anywhere, and do.

Among the companies working on overdose remedies is Amphastar Pharmaceuticals Inc., of Rancho Cucamonga, Calif., which Piper Jaffray analyst David Amsellem deemed "well-positioned for further value creation," with "the potential for significant further growth from the company's naloxone products for opioid overdose." Earlier this month, he described in a report the favorable-for-Amphastar "combination of limited competition outside of the hospital setting (particularly regarding non-injectable products), limited competition within the hospital (only two other consequential naloxone market participants), and the reality of the U.S. opioid epidemic." It all, in his view, "points to high visibility into significant growth for Amphastar's naloxone franchise in 2017" and beyond.

Amphastar's PDUFA date with its intranasal form of naloxone falls on Feb. 19, 2017, as the company moves forward with its injectable version, given subcutaneously. Strong year-over-year sales were recorded lately, a price hike having taken effect in October 2014, when Amphastar doubled the price. Could the company's intranasal form cut into its own injectable sales? Amsellem doesn't believe so, "even though Amphastar does distribute an injectable stock keeping unit that can be fitted with an intranasal adapter that is bought separately. Our thinking here is that even though customers outside of the hospital (mainly first responders) account for around 40 percent of volumes for Amphastar's injectable, we expect that the availability of a true intranasal form of naloxone will ultimately drive more municipalities and even retail pharmacies to stock the product given the extent and severity of the opioid epidemic."

In the ring with Amphastar are the likes of New York-based Pfizer Inc. and Mylan NV, of Canonsburg, Pa. Both sell injectable naloxone, respectively taking up 13 percent and 4 percent of year-to-date sales, according to IMS Health, whereas Amphastar's took 19 percent, with apparently no pending filings for other injectables.

Kaleo Pharma Inc., of Richmond, Va., sells an intramuscular and subcutaneous injectable form called Evzio, delivered by way of an auto-injector device made for caregiver use and available through prescription. IMS said Evzio has sold $95 million year to date. "This is potentially fertile ground (i.e., retail setting) for volume capture by Amphastar's intranasal product, in our view," wrote Amsellem.

Adapt Pharma Ltd. markets an intranasal version called Narcan – developed by New York-based Lightlake Therapeutics Inc. – but prescriptions and sales, according to IMS, have been "modest," he said, at 14,500 and $5 million, respectively, over the past 12 months. Hikma Pharmaceuticals plc, of Amman, Jordan, is in the game as well. (See BioWorld Today, Nov. 20, 2015.)

Some threats may loom. Buena, N.J.-based Teligent Inc. last November completed its buyout of Alveda Pharmaceuticals Inc., of Toronto, bringing aboard a collection of injectable generic assets that includes an injectable naloxone that the firm might commercialize. Insys Therapeutics Inc., of Phoenix, has a naloxone sublingual spray that won fast track status from the FDA and could be filed for approval next year.

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