The novel rapid formulation of intravenous dantrolene (NPJ5008) versus standard dantrolene (Dantrium®)®): A clinical part-randomised phase 1 study in healthy volunteers
Authors' conclusion
NPJ5008 showed comparable pharmacokinetic and safety profiles to Dantrium®, while reducing dantrolene dose preparation/administration times, potentially reducing patient complications/healthcare resourcing in malignant hyperthermia.
Study context
- Population
- Healthy male and female individuals, single centre in the UK, April to July 2021
- Participants
- 21 healthy volunteers
- Comparison
- NPJ5008 vs Dantrium®
- Primary endpoint
- Overall dantrolene exposure: AUC 0 to last measurable concentration and AUC 0 to ∞ (bioequivalence, 80 to 125% acceptance interval)
Methodological detailsopen-label, 1 : 1 randomised crossover (part 1), single-arm (part 2), single-centre, laboratory simulation
- Open-label
- 1 : 1 randomised crossover (part 1)
- Single-arm (part 2)
- Single-centre
- Laboratory simulation
Primary result
As reported in the abstract
AUC 0 to last and AUC 0 to ∞ (adjusted geometric mean ratio NPJ5008 vs Dantrium®)
Adjusted geometric mean ratio (AUC 0 to last)
90.24 %
NPJ5008
Adjusted geometric mean ratio (AUC 0 to ∞)
90.44 %
NPJ5008
Further findings
Preparation and administration step timings (pharmacy and simulation data)
- Every step in preparation and administration faster for NPJ5008 than Dantrium®
- 26 to 69%
Safety
Adverse events
- No new safety issues; AEs of similar magnitude across treatments and related to pharmacological properties of dantrolene
Original publication
The novel rapid formulation of intravenous dantrolene (NPJ5008) versus standard dantrolene (Dantrium®)®): A clinical part-randomised phase 1 study in healthy volunteers. Eur J Anaesthesiol. Published 5 March 2024. doi:10.
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