Clinical Trials

Date: 2016-07-26

Type of information: Treatment of the first patient

phase:

Announcement: treatment of the first patient

Company: Neuroderm (Israel)

Product: ND0701 (apomorphine-base)

Action mechanism: dopamine agonist. ND0701 is based on a novel, proprietary formulation of concentrated apomorphine-base that was designed to significantly improve patient convenience by enabling its administration via a small, disposable, low-volume patch-pump, and to improve the local tolerability and pain associated with current commercially available subcutaneously administered continuous apomorphine-HCl.

Disease: Parkinson's disease

Therapeutic area: Neurodegenerative diseases

Country:

Trial details: Trial 101 is a crossover, randomized, two-sequence, 12 hour bioequivalence study that compares the pharmacokinetics, safety and tolerability of ND0701 with those of a reference commercial apomorphine product.

Latest news:  

• • On July 26, 2016, NeuroDerm announced that dosing has started in its EU bioequivalence trial (Trial 101) comparing ND0701, the company’s continuous, subcutaneously delivered liquid apomorphine-base formulation, with commercial continuous, subcutaneously delivered apomorphine-HCl. Apomorphine is the most potent dopamine agonist used for the treatment of Parkinson's disease. The company's EU regulatory pathway for ND0701 is based on the demonstration of bioequivalence vs. commercial apomorphine-HCl in healthy volunteers. As previously disclosed, the company is currently designing the clinical and regulatory development plan of ND0701 in the United States.
• Trial 101 is expected to enroll a total of 18 healthy volunteers and is expected to be completed in the fourth quarter of this year.

Is general: Yes