Arymo ER – Latest Addition to the Abuse Deterrent Opioids Market
Last week, the FDA approved Arymo ER, an abuse-deterrent formulation of morphine sulfate extended release tablets, marketed by Egalet Corporation. Arymo ER comes in three dosage strengths: 15mg, 30mg, and 60mg and slated to hit the market first quarter 2017. Arymo ER is the latest addition to the growing list of abuse-deterrent opiates like Troxyca ER, Xtampza ER, MorphaBond ER, and Hysingla ER, to name a few. In order for a formation to be considered as abuse-deterrent, it has to have at least one of the properties below:
- Physical/Chemical barriers
- Prevent chewing, crushing, cutting, grating or grinding
- Resist extraction of opioid using solvents like water, alcohol or organic solvents
- Agonist/Antagonist combinations
- Adding of opioid antagonist to interfere with the release of the opioid if the drug is tampered with. For example, the substance that acts as an antagonist doesn’t get activated unless the product is crushed and injected or snorted.
- Substances are added to dose form to produce an unpleasant effect if dose form manipulated prior to ingestion or a higher dose than prescribed is used
- Delivery System
- Formulations such as implants and depot injectable that are more difficult to manipulate
- Product contains a pro-drug that lacks opioid activity until it is transformed in the gastrointestinal tract
- Using 2 or more of the above methods to deter abuse
Arymo ER is made using the company’s proprietary Guardian Technology, which uses physical and chemical barriers to make the tablets resistant to manipulation for the purpose of misuse and abuse. The FDA will allow Egaret to label the product as abuse deterrent via the intravenous route only. The agency rejected the claim that the drug was abuse deterrent in the oral form. The agency, also, did not approve the claim of deterrence via the nasal route due to a marketing exclusivity that MorphaBond ER (morphine) currently holds until 2018.
Since the FDA issued guidance to pharmaceutical industry on abuse-deterrent formulations in 2013, found here, there have been seven new opioids with abuse deterrent technology introduced into the market and several have been reformulated. Last year, Xtampza ER (oxycodone) and Troxyca ER (oxycodone + naltrexone) were both approved by the FDA. Both are capsule formulations that can be swallow whole or sprinkled over food and ingested immediately without chewing. MorphaBond ER (morphine) was approved in 2015. MorphaBond ER uses proprietary technology to prevent abuse via oral, injection, inhalation, and insufflation. MorphaBond ER was also granted exclusivity to claim abuse deterrent via inhalation route. Hysingla ER (hydrocodone), Embeda ER (morphine + naltrexone), and Targiniq ER (oxycodone + naltrexone) were all approved in 2014.
Under review by the FDA are four new abuse deterrent opioids: KP201 IR, CEP-33237 ER, and Remoxy ER. KP201 IR, from KemPharm Inc., is an acetaminophen-free immediate release hydrocodone that, if approved, will be the first abuse deterrent immediate release hydrocodone formulation on the market. TEVA Pharmaceutical’s, CEP-33237 is an acetaminophen-free extended release formulation of hydrocodone. TEVA is requesting approval for abuse deterrence via oral and nasal routes. Remoxy ER, from Pain Therapeutics, was submitted for approval in 2016, but did not receive approval for any abuse deterrent labeling by the FDA. Pain Therapeutics is planning on further discussions with the agency. It is unclear when any of these investigative drugs will finally receive approval.