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Safinamide (Newron Pharmaceuticals).

¹University of Sunderland School of Sciences, Tyne and Wear, UK. Paul.Chazot@sunderland.ac.uk

Current Opinion in Investigational Drugs (London, England : 2000)

|September 27, 2001

Summary

Safinamide, a novel drug targeting epilepsy and Parkinson's disease, has shown promising results in early trials. It acts as a sodium and calcium channel modulator and MAOB inhibitor, demonstrating good tolerability and bioavailability.

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Area of Science:

Neuroscience
Pharmacology

Background:

Safinamide (PNU-151774E) is a dual-acting agent modulating sodium and calcium channels and inhibiting monoamine oxidase B (MAOB).
It is under development for epilepsy, Parkinson's disease (PD), pain, and stroke.

Purpose of the Study:

To evaluate the safety, tolerability, bioavailability, and pharmacokinetics of safinamide in humans.

Main Methods:

Two Phase I clinical trials were conducted: a single ascending dose study and a steady-state study at three doses.
Pharmacokinetic parameters were assessed.

Main Results:

Safinamide was found to be well tolerated in Phase I trials.
The drug exhibited good bioavailability and linear pharmacokinetic properties.

Conclusions:

Safinamide demonstrates favorable safety and pharmacokinetic profiles, supporting its continued development for neurological disorders like epilepsy and Parkinson's disease.

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