Zyla Life Sciences (fka ZCOR)

[realfast95]

Earnings call transcript - note 2

When looking at the commercial opportunity for ARYMO ER, it's important to remember that over 98% of the extended-release Morphine market is in easy to abuse forms. ARYMO ER was approved with an abuse-deterrent label and is the third registered abuse-deterrent extended release morphine product.

With only one of these products on the market Embeda, we believe ARYMO ER will launch, when launched later this month will be an attractive option for healthcare providers and for patients.

http://seekingalpha.com/article/4053766-egalets-eglt-ceo-bob-radie-q4-2016-results-earnings-call-transcript?page=3

FDA Approves Abuse Deterrent Labeling for EMBEDA® (morphine sulfate and naltrexone hydrochloride) Extended-Release (ER) Capsules CII

EMBEDA is the first and only approved ER morphine specifically designed to deter oral and intranasal abuse when crushed
Friday, October 17, 2014 - 4:38pm
EDT

Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration (FDA) has approved an updated label for EMBEDA® (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, for oral use, CII, to include abuse-deterrence studies. The updated label states that EMBEDA has properties that are expected to reduce abuse via the oral and intranasal (i.e., snorting) routes when crushed. However, abuse of EMBEDA by these routes is still possible. The updated label also includes data from a human abuse potential study of intravenous (IV) morphine and naltrexone to simulate crushed EMBEDA. However, it is unknown whether the results with simulated crushed EMBEDA predict a reduction in abuse by the IV route until additional postmarketing data are available. EMBEDA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Pfizer expects EMBEDA will be available in the U.S. in early 2015.

http://www.pfizer.com/news/press-release/press-release-detail/fda_approves_abuse_deterrent_labeling_for_embeda_morphine_sulfate_and_naltrexone_hydrochloride_extended_release_er_capsules_cii