Newsroom > Ethypharm has obtained marketing authorisations for the first Immediate Release orodispersible tablets of morphine in Germany, France and the United Kingdom.
Thursday 02 December 2021 - 13h00
Ethypharm has obtained marketing authorisations for the first Immediate Release orodispersible tablets of morphine in Germany, France and the United Kingdom.
Saint-Cloud, France – December 2nd, 2021 – Ethypharm has successfully used a European decentralized procedure to obtain its marketing authorisations (MA) for the 1st Immediate-Release orodispersible tablets of morphine in a broad range of dosages. This full in-house development will help Ethypharm to respond to some patients’ specific needs in the field of pain in the three largest European morphine markets: Germany, France and the United Kingdom.
The Central Nervous System (CNS) is one of Ethypharm’s two areas of focus. In its commitment to help manage severe pain, the company is already offering several analgesics, including Immediate-Release and Sustained-Release morphine products.
Having a choice of dosages and forms is critical for prescribers to customise pain treatments according to their patients’ needs. In that regard, certain populations have special needs that might currently not be fully met. For example, both the elderly and the children population would need lower dosages than currently exists in the market in an oral solid dose form; these two populations groups may also have swallowing difficulties.
“We are proud of this successful development of the first Immediate-Release orodispersible tablet of morphine”, explains Marianne Henrion, Group R&D Director at Ethypharm. “Our newly approved product offers a broad range of dosages, introducing the lowest strengths of oral solid dose morphine in the European market (1mg and 2.5mg).”
“This Marketing Authorisation confirms our ability to answer patients’ needs” concludes Jean Monin, Chief Commercial Operations Officer at Ethypharm. “Our product is adapted for all patients, from children over 6-months-old to the elderly. Expected in the first half of 2022, this will be our first product launch by our own affiliates on a European scale.”
Ethypharm is a European pharmaceutical company focused on two areas: the Central Nervous System and Hospital Injectables. Ethypharm markets its drugs directly in Europe and China, and with partners in North America and the Middle East where its drugs are in high demand. The Group employs circa 1,750 people, mainly in Europe and China. Ethypharm works closely with authorities and healthcare professionals to ensure the appropriate use of, and access to, its medicines, by as many people as possible.