Trial Profile
Single-center, randomized, double-blind, double-dummy, active and placebo-controlled, five-period crossover trial of intranasal morphine [Egalet-001] versus MS Contin for the treatment of pain in non-dependent, recreational opioid users [Category 3 abuse-deterrent intranasal HAL study]
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 11 Jul 2019
Price :
$35
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At a glance
- Drugs Morphine (Primary) ; Morphine
- Indications Pain
- Focus Pharmacodynamics
- Sponsors Zyla Life Sciences
- 15 Dec 2017 According to an Egalet Corporation media release, this data was previously excluded from the label at original new drug application (NDA) approval due to exclusivity granted to another company. The final approval is expected to be granted when the exclusivity period expires on October 2, 2018.
- 15 Dec 2017 According to an Egalet Corporation media release, Based on the results of this trial, the US FDA has granted tentative approval for an expanded label for ARYMO ER (morphine sulfate) extended-release (ER) tablets C-II 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.
- 20 May 2017 Results of this and another phase I study presented at the 36th Annual Scientific Meeting of the American Pain Society.