Meta-analysis confirms Myopridin® (Pridinol Mesilate) as an efficacious and well-tolerated alternative to the current standard of care for muscular pain & spasm

A meta-analysis of study data on the efficacy of Pridinol in 4,607 patients with muscular pain, presented at the German Pain Society Congress (October 19^th-October 23^rd), concludes that Pridinol shows a significantly superior analgesic effect to placebo. The two-part poster, authored by Dr Michael Überall from the Institute of Neuroscience, Algesiology and Paediatrics, Nuremburg , Germany, discusses the “Efficacy of Pridinol in Muscular Pain” and confirmed the efficacy of Pridinol with good compliance in patients.

• The meta-analysis included data from three randomised (active / placebo) controlled studies (RCS) and 23 adjusted non-interventional trials (NIS). In all of the randomised controlled studies included in the analysis, and 69.9% of the NIS, the response for Pridinol was significantly better than that for placebo. For the NIS, the response rates were on average 91.5% and the conservatively weighted placebo response( GPR) at 60.5% (p<0.001) for the RKS-corrected PE under Pridinol in the NIS vs GPR, and a NNT of 3*
• In all the randomised controlled studies (RCS) included in the analysis, the response rate for Pridinol was significantly better than that for placebo (p<0.001)
• In the RCS, the primary endpoint showed significant superiority of Pridinol (74.6%) over placebo (49.7%) p< 0.001, NNT: 4

In addition, the second part of the poster displayed at the Congress, authored by Dr Überall, detailed  PriMePain register data analysing  1,133 patients from the PraxisRegister Schmerz (a Patient Registry, internet-based documentation system in pain management developed in co-operation with the German Society for Pain Medicine– DGS). It concluded that Pridinol proves to be an effective and well-tolerated alternative for the treatment of muscular pain.  Over the evaluation period of 9 weeks, patients across an age range of 18-85 being treated for acute and subacute muscular pain were documented. The conclusions that can be drawn from this robust database include evidence for the safety and tolerability of Pridinol, further clarification around duration of treatment and dosage, information on pain reduction scores, the potential to reduce the intake of other analgesic drugs and absence of adverse drug reactions (ADRs).

Key findings from Dr Überall and the research team¹ include:

• Under therapy, 94.4%/79.8% documented clinically relevant pain relief, 88.1%/66.8% an improvement in pain-related everyday impairments, and 32.0/4.5% an improvement in their overall well-being ≥MCID/50% vs BL. Treatment was started with three tablets of Pridinol per day and the treatment duration was 12±10.2 (median 7, range 3-63) days
• Only 6% of patients reported any side effects; confirming the safety and tolerability of the treatment
• Pridinol showed a statistically significant reduction in the intake of other analgesic drugs, with 30.8% of patients documenting complete cessation of other analgesic therapies
  • Significant decreases were recorded for non-analgesics (-37.1%), NSAID’s (-34.4%) and low-potency opioid analgesics (-24.1%)

Pridinol is a well-established prescription medication licensed for central and peripheral muscle spasms: lumbar pain, torticollis and general muscle pain in adults. In the UK, Pridinol is marketed as Myopridin® 3mg tablets, providing fast and sustained reduction in pain, breaking the cycle of pain-spasm-pain, improving mobility and allowing patients to get on with their lives^2,3. Myopridin 3mg tablets (recommended dosage TDS) costs £7.80 for a 10 day course of treatment – simple dosing with no need for titration and treatment can be extended if required^{2, 4}.

Mark Inker, General Manager at mibe Pharma comments, “This meta-analysis and patient registry data provides valuable evidence to add to the existing portfolio of data which supports the use of Pridinol for patients with muscular pain. The strength of data and the positive patient response reinforces Myopridin^® as a viable, efficacious and well-tolerated alternative to existing treatments with no known potential for addiction. Myopridin^® should provide health care professionals with the confidence to consider Myopridin^® early in the treatment pathway for patients with low back pain or neck pain and associated spasm. With the study reporting a 30.8% reduction in the use of other analgesic therapies, this confirms that Myopridin^® may support the de-prescribing of other medicines commonly prescribed for lower back pain and neck pain, that are associated with abuse and dependence ^2,4.”

The results of the meta-analysis and the PriMePain register data clinical papers are due to be submitted separately for publication.

*NNT: Number needed to treat: The average number of patients who need to have the treatment or other intervention for one of them to get the positive outcome in the time specified

References:

1. Authors: Dr Michael Uberall, Institute of Neuroscience, Algesiology and Paediatrics, Dr Ute Essner, O.Meany Consultancy GmbH, Phillip Uberall, O.Meany Consultancy GmbH and Dr Gerhard Muller-Schwefe, Pain and Palliative Centre Goppingen
2. MYTOS (My Therapeutic Observational Study) with Myoson® direct 2005 (Data on file KM-01)
3. Roland MO. A critical review of the evidence for a pain-spasm-pain cycle in spinal disorders. Clin Biomech (Bristol, Avon) Actions. 1986 May;1(2):102-9
4. Myopridin SmPC available at https://www.medicines.org.uk/emc/product/11957 Date accessed June 2021