CNS Drugs (2018) 32:443–454 https://doi.org/10.1007/s40263-018-0512-x OR IGINAL RESEARCH ARTIC L E ND0701, A Novel Formulation of Apomorphine for Subcutaneous Infusion, in Comparison to a Commercial Apomorphine Formulation: 28-Day Pharmacokinetic Study in Minipigs and a Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Relative Bioavailability 1 2 3 3 3 • • • • • Yuval Ramot Abraham Nyska Liat Adar Cecile Durlach Danny Fishelovitch 4 4 3 5 • • • • Giuseppe Sacco Rosa Anna Manno Sheila Oren Itay Perlstein Oron Yacobi-Zeevi Published online: 10 April 2018 Springer International Publishing AG, part of Springer Nature 2018 Abstract Results (1) Preclinical study: No systemic toxicity was Background Subcutaneous apomorphine is used for the observed in apomorphine-treated minipigs, but local skin treatment of Parkinson’s disease (PD); however, infusion site reactions were observed at the infusion sites. These effects reactions are a common adverse event (AE), which can lead were less frequent and less severe and recovery was more to treatment discontinuation. Apomorphine formulations that rapid for ND0701 compared with APO-go . (2) Phase I are more tolerable and convenient for use are needed. study: Both formulations were safe and well tolerated Objective Our aim was
CNS Drugs – Springer Journals
Published: Apr 10, 2018
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