19th Apr 2016 08:47
LONDON (Alliance News) - Oxford Pharmascience Group PLC on Tuesday said has received "clear and positive" feedback from the Medicines & Healthcare products Regulatory Agency as it works to obtain marketing authorisation for OXPzero Ibuprofen in the UK.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health.
Oxford Pharmascience currently has OXPzero variants of two non-steroidal anti-inflammatory drug molecules in clinical development, OXPzero Ibuprofen and OXPzero Naproxen. Both products leverage Oxford Pharmascience's technology platform which aims to mask the bitter taste and irritation of NSAIDs and to provide reduced risk of gastrointestinal side effects.
"The MHRA's feedback has provided clear direction for the pivotal studies required to gain approval of marketing authorisation for OXPzeroTM Ibuprofen. This gives us a clear understanding of the timelines and associated investment required. We believe this puts us in a strong position as we continue with our partnering discussion process for both OXPzero Ibuprofen and Naproxen," Chief Executive Marcelo Bravo said in a statement.
Shares in Oxford Pharmascience were trading up 4.9% at 4.59 pence on Tuesday morning.
By Karolina Kaminska; [email protected] @KarolinaAllNews
Copyright 2016 Alliance News Limited. All Rights Reserved.
Related Shares:
Oxford Pharmascience Group