The clinical HAL study demonstrated that, in nondependent, recreational opioid users, the abuse potential of manipulated Egalet-001 taken intranasally was significantly lower than that for manipulated MS Contin (morphine sulfate controlled-release).
It was a single-center, randomized, double-blind, double-dummy, active and placebo-controlled, five period crossover study which assessed the abuse potential of Egalet-001 versus MS Contin in 46 nondependent, recreational opioid users when taken intranasally.
Participants treated with MS Contin had a statistically significant improvement in two measures, compared with placebo: overall quality of sleep (week 2) and less trouble falling asleep because of pain (weeks 3 and 4).
The safety profiles of Avinza and MS Contin were similar.
With the demonstration of bioequivalence across the dosage range of 15 mg, 30 mg and 60 mg for Egalet-001 to MS Contin
, we now have the data that supports a BE path toward registration for our abuse-deterrent, extended-release morphine product candidate," said Jeffrey Dayno, MD, chief medical officer at Egalet.
AVINZA had a positive effect on physical functioning in osteoarthritis patients who completed up to 30 weeks of treatment, and was statistically superior to MS Contin
on some occasions," said Dr.
In addition, the company announced positive top-line results from a recently completed pivotal study (Study 067-EG-012) that demonstrated bioequivalence of Egalet-001 15 mg and 30 mg dosage strengths to MS Contin
One patient withdrew from the MS Contin
treatment period due to drowsiness in the morning and insomnia in the evening.
The first study compared MoxDuo CR (30mg morphine SO4/20mg oxycodone HCl) to the pharmacokinetic profiles of the same doses of MS Contin
(30mg morphine SO4) and OxyContin (20 mg oxycodone HCl) in 10 healthy adult human subjects using a three-way crossover design.
Kao has developed several extended release dosage forms, including first to file generic formulations bioequivalent to OxyContin and MS Contin
In accordance with the recently approved IND filed with the US Food and Drug Administration (FDA), this two-part pilot study will compare the rate at which key components of the controlled-release formulation are absorbed, distributed, metabolized and eliminated by the body to the pharmacokinetic profiles of co-administered MS Contin
30 mg (sustained release morphine) and Oxycontin 20 mg (sustained release oxycodone).
Prior to the study, these patients were using a variety of approved oral and transdermal opioid medications such as MS Contin
, Oxycontin, Duragesic and Methadone.