Egalet Corp (NASDAQ:EGLT) has announced that the FDA gave it the nod for its application for ARYMO™ ER (Morphine Sulfate) Extended-Release Tablets.
The company has been developing the drug for the treatment of pains that so severe that they require daily doses of medicine. ARYMO ER is also used to treat long-term opioid which does not have adequate alternative treatments. The pharmaceutical company’s Managing Director and Chief Medical Officer Jeffrey Dayno stated that the FDA’s approval for the new drug was a big step towards the approval of the company’s first Guardian™ Technology product candidate.
Mr. Dayno also added that the company looks forward to cooperating with the FDA during the review period so that the product can be released into the market as soon as possible. The FDA has revealed that its plan on the matter is first to form an advisory committee that will handle the application.
The new drug from the company will be used to treat chronic pains that often tend to continue longer than three months after a person is healed from an injury. Such pains are often common in arthritis cases, migraines, and lower back pains among others. The company, therefore, believes that the drug will be very appreciated and useful to persons who suffer from such conditions.
The firm’s Guardian technology has a wide variety of applications, and it has mostly been used to make prescription medication that has previously been abused in forms that cannot be abused. ARYMO ER has shown both chemical and physical features that are deterrent to common forms of misuse such as size reduction. They also don’t allow chemical extraction and cannot be injected using a syringe because of their viscous nature when in contact with a liquid. The company claims that these are vital features aimed at preventing misuse, either accidentally or intentionally.
The Guardian Technology can be used on other pharmaceutical products and Egalet currently has two products that have already been approved; SPRIX® (ketorolac tromethamine) Nasal Spray and OXAYDO™ (oxycodone HCI, USP) tablets for oral use only.