Publication about a new formulation for morphine sulfate
November 10, 2022
Decreasing moderate-to-severe pain using an opioid, a fine-tuning process
Morphine sulfate is a well-established first-line opioid used to treat moderate-to-severe pain. In adults and adolescents with cancer pain, the World Health Organization (WHO) recommends reducing pain to a level that allows patients to have an acceptable quality of life.
Determining the right dosage of morphine sulfate to be used requires evaluating the origin and type of pain, and choosing the drug formulation that will be the most effective. Oral immediate-release or modified-release tablets or capsules, oral solutions/suspensions, or parenteral forms of morphine sulfate are available at various dosages. The benefit of pain relief must be balanced against the risk of adverse effects and overdose, which may result in respiratory depression. The WHO, the European Society for Medical Oncology (ESMO), the Centers for Disease Control and Prevention (CDC) and the American Geriatrics Society (AGS) recommend using the least invasive route (i.e., oral), and the lowest dose possible for titration to the minimal effective opioid dose for managing pain relief.
A panel of morphine sulfate orodispersible tablets (1 à 30 mg)
Our medical writing team has helped the Ethypharm group to write an article about a panel of morphine sulfate (1 à 30 mg) orodispersible tablets (ODTs), which will be suitable for patients with swallowing difficulties such as pediatric and elderly patients. In a pilot study, the pharmacokinetic properties and relative bioavailability of the 30-mg morphine sulfate ODT was compared with three oral immediate-release formulations (a tablet form, a capsule form and a solution). Two pivotal studies assessed the bioequivalence of the 30-mg and 5‑mg morphine sulfate ODTs and the reference tablet form. The results of these studies, together with analyses of the comparative safety, tolerance and palatability of the ODTs and reference products, are described in the article that has just been published in the journal “Clinical Drug Investigation”.
Please note that there will be a session dealing with « the appropriate use of opioids » at the 22nd national meeting of the Société Française d’Etude et de Traitement de la Douleur (SFETD), which will be held at the Grand Palais in Lille (France) from November 16 to 18, 2022.
The expertise of Santé Active Edition – Synergy Pharm
Pain management is one of the fields of expertise of our medical writing team not only in the context of scientific publications, but also for marketing authorization applications (MAA).