ASSESSMENT OF THE USE OF THE VEMONIS FEMI® MEDICINAL PRODUCT IN THE TREATMENT OF DYSMENORRHEA IN EVERYDAY CLINICAL PRACTICE (ADM/VEM/2020)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/35006
• EU PAS number:
  EUPAS35005
• Study ID:
  35006
• Official title and acronym:
  ASSESSMENT OF THE USE OF THE VEMONIS FEMI® MEDICINAL PRODUCT IN THE TREATMENT OF DYSMENORRHEA IN EVERYDAY CLINICAL PRACTICE (ADM/VEM/2020)
• DARWIN EU® study:
  No
• Study countries:
  Poland
• Study description:
  The composite preparation containing sodium metamizole, caffeine and drotaverine hydrochloride VEMONIS FEMI® is used for the symptomatic treatment of pain, pain associated with smooth muscle spasms (renal colic, dysmenorrhea, intestinal colic, irritable bowel syndrome, cholecystitis, cholangitis) when the use of other drugs is contraindicated or ineffective. Metamizole is a pyrazolone derivative, belongs to NSAIDs with analgesic, spasmolytic and antipyretic effects. The analgesic effect of this substance is based on inhibition of COX3 occurring mainly in the CNS, which results in decreased synthesis of PGE2, which reduces the sensitivity of nociceptors to pain mediators. Metamizole metabolites are CB1, which are part of the descending antinociceptive system. The third mechanism associated with the analgesic properties is the activation of the endogenous opioid system. Metamizole differs from other NSAIDs as it has a clear spasmolytic effect. The mechanism responsible for this effect may be the inhibition of intracellular release of calcium ions, which causes smooth muscle relaxation. Furthermore, it inhibits the accumulation of inositol phosphate by direct inhibition of phospholipase C or by impairing the activation of the receptor that is combined with protein G. Caffeine is a naturally occurring methylxanthine used as a CNS stimulant. Its other effects: relaxation of smooth muscles, stimulation of the heart muscle and stimulation of diuresis. It’s also effective in treating certain types of headaches. Caffeine inhibits phosphodiesterase, an enzyme inactivating the cyclic adenosine monophosphate. It shows antagonistic effects against adenosine receptors A(1), A(2A), A(2B) involved in nociception. It is an additive to many painkillers because it increases their analgesic effect by accelerating their absorption. Drotaverine is a relaxant, structurally similar to papaverine but with a much stronger effect. It is a selective inhibitor of PDE4 in smooth muscles.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Europharma

Study timelines

Date when funding contract was signed

Planned: 05/02/2020

Actual: 05/02/2020

Study start date

Planned: 15/04/2020

Actual: 15/04/2020

Data analysis start date

Planned: 30/07/2020

Date of final study report

Planned: 30/09/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Adamed Pharma S.A.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable