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Morphine sulfate pentahydrate is a chemically synthesised opioid substance classified as morphine under the Anatomical Therapeutic Chemical code N02AA01.[1] It is authorised as a medicine in Germany, where it is supplied by Hameln Pharma GmbH as Morphin-hameln 100 mg Injektionslösung, a solution for injection given intravenously.[1] In the clinical trial record provided, this medicine was used as a comparator rather than as the substance under investigation.[1]
Morphine is an opioid analgesic, a class of medicines that act on opioid receptors in the central nervous system to reduce the sensation of pain.[2] The trial data describes morphine sulfate pentahydrate as a comparator medicine used in the management of postoperative pain, a setting where opioids are used to control pain after surgery.[1]
In the trial data, morphine sulfate pentahydrate is recorded as a solution for injection administered intravenously.[1] The product name given in the registry is Morphin-hameln 100 mg Injektionslösung.[1] The medicines.org.uk database lists morphine sulfate pentahydrate as an active ingredient in a 1 mg/ml solution for injection supplied by hameln pharma ltd.[3]
The clinical trial data for morphine sulfate pentahydrate contains one completed Phase 3 interventional study with 160 participants.[1] In this trial, morphine sulfate pentahydrate was used as a comparator, while the investigational treatment was fentanyl nasal spray compared with placebo nasal spray for the management of postoperative pain.[1] The study was a multi-center trial designed to assess the efficacy of fentanyl nasal spray in combination with an applicator compared with placebo.[1] The primary outcome measured the survival distribution from the start of treatment with the first dose of study medication until termination of the trial due to inadequate analgesia, as required by the patient or felt necessary by the investigator, within the first 24 hours after the start of treatment, with non-terminating patients censored at 24 hours.[1] Pain caused by orthopedic surgery served as the model for postoperative pain in this study.[1]
The supplementary sources provided do not contain specific information about side effects of morphine sulfate pentahydrate. For detailed safety information, consult the patient leaflet or summary of product characteristics for the specific morphine product, such as the Morphine Sulfate 1 mg/ml solution for injection listed on medicines.org.uk.[3]
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