Medincell’s Partner Teva Provides New Update on Pivotal Clinical Phase 3 of Investigational Olanzapine Long-Acting Injectable (LAI)
- No PDSS* observed after completion of c.99% of the targeted injections for submission
- Confirmation that full phase 3 safety results are on track for H2 2024
-
Positive phase 3 efficacy results have already been announced in
May 2024 (read the full PR)
MONTPELLIER,
Olanzapine LAI is an investigational once-monthly subcutaneous long-acting injection of the atypical antipsychotic Olanzapine. It has the potential to be the first long-acting Olanzapine with a favorable safety profile as other LAIs of Olanzapine have been associated with a FDA black box warning for PDSS that limits their use.
Teva is fully responsible for leading the development and commercialization of Olanzapine LAI.
*PDSS = Post injection Delirium/Sedation Syndrome
About
UZEDY® and SteadyTeq™ are registered trademarks of
This press release may contain forward-looking statements, particularly concerning the progress of the Company's clinical trials. Although the Company considers that its forecasts are based on reasonable assumptions, any statements other than statements of historical fact that may be contained in this press release relating to future events are subject to change without notice, to factors beyond the Company's control and to the Company's financial capabilities.
These statements may include, but are not limited to, any statements beginning with, followed by or including words or expressions such as "objective", "believe", "expect", "aim", "intend", "may", "anticipate", "estimate", "plan", "project", "will", "may", "probably", "should", "could" and other words or expressions of similar meaning or used in the negative. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control which may cause actual results, performance or achievements of the Company to differ materially from those anticipated or implied by such statements.
A list and description of such risks, hazards and uncertainties can be found in the documents filed by the Company with the Autorité des Marchés Financiers (AMF) pursuant to its regulatory obligations, including in the Company's document de base, registered with the AMF on
This press release is published for information purposes only. The information contained herein does not constitute an offer to sell or a solicitation of an offer to buy or subscribe for securities of the Company in any jurisdiction whatsoever, particularly in
View source version on businesswire.com: https://www.businesswire.com/news/home/20240904030878/en/
David Heuzé - Head of
david.heuze@medincell.com / +33 (0)6 83 25 21 86
grace.kim@medincell.com / +1 (646) 991-4023
Investors Relations France
medincell@newcap.eu / +33 (0)1 44 71 94 94
Media Relations
Nicolas Mérigeau
medincell@newcap.eu / +33 (0)1 44 71 94 94
Source: