A Phase II, Multicenter, Double Blind, Double Dummy, Randomized, 2 Arms Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome

A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome

Start Date18 Dec 2020

Sponsor / Collaborator

CHIESI Farmaceutici SpA

100 Clinical Results associated with CHF-6563

100 Translational Medicine associated with CHF-6563

100 Patents (Medical) associated with CHF-6563

Literatures (Medical) associated with CHF-6563

01 Feb 2024·The Journal of Pediatric Pharmacology and Therapeutics

The Bioavailability of CHF6563, an Ethanol-Free, Sublingual Neonatal Buprenorphine Formulation: A Bridging Study Conducted in Adults

Article

Author: Bocchi, Maria ; Santoro, Debora ; Kraft, Walter K ; Barneschi, Irene ; Cella, Massimo

OBJECTIVESublingual buprenorphine has demonstrated efficacy for treatment of the neonatal opioid withdrawal syndrome (NOWS), but the current formulation used in clinical practice contains 30% ethanol. Ethanol as a pharmacologically active excipient ideally should be removed from neonatal formulations. The objective of this study was to determine the relative bioavailability of a novel ethanol-free formulation (CHF6563) compared with the commonly used ethanolic solution in a phase I, open-label, 2-period, single-dose, crossover study in healthy adults.METHODSEighteen adult opioid-naïve volunteers were administered one of the formulations in a randomized crossover treatment. After a 10-day washout period, subjects received the other formulation. Serial blood samples were drawn for pharmacokinetic analysis over 48 hours.RESULTSThe geometric mean ratio (90% CIs) of the ethanol-free buprenorphine solution AUC0–last was 0.80 (0.65–0.99) and Cmax was 0.81 (0.66–0.99) compared with reference ethanolic formulation. The ethanol-free formulation had a greater degree of intersubject variability than the ethanol-containing reference formulation (coefficient of variation of 59% vs 31.5%, respectively, for AUC0–last).CONCLUSIONSIn an adult population, a novel ethanol-free formulation of buprenorphine containing widely used excipients demonstrated a slight decrease in bioavailability when compared with an ethanolic solution. These results will inform those seeking to develop ethanol-free pediatric drug formulations.

100 Deals associated with CHF-6563

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Indication	Highest Phase	Country/Location	Organization	Date
Neonatal Abstinence Syndrome	Discovery	US	CHIESI Farmaceutici SpA	18 Dec 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04104646 (NOWSHINE, CTgov)	Phase 2	Neonatal Abstinence Syndrome	7	CHF6563+Morphine matched placebo (CHF6563)	llwevfhttb(dposssgvzv) = tbqggjjuhv qrdlrvvibm (rmifsuayze, jjcajaqnam - gcxxgdecqs) View more	-	03 Aug 2023
				CHF6563 matched placebo+Morphine (Morphine)	llwevfhttb(dposssgvzv) = iyyrfqthss qrdlrvvibm (rmifsuayze, xrkygczfic - fcnuphawgb) View more

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