An evaluation of the efficacy and value of CVT-301 for the treatment of Parkinson’s disease

ABSTRACT

Introduction: Levodopa is the most effective drug in the treatment of Parkinson’s disease, but its chronic treatment is linked to the occurrence of motor complications with fluctuations of motor performance and dyskinesia. Unpredictable OFF episodes can be severe and disabling and current rescue medications cannot always be used safely. Rescue therapy is characterized by a rapid and predictable ON response and the safety profile of levodopa will represent a major advantage for patients affected by unresponsive OFF episodes.

Areas covered: CVT-301 is a new inhaled formulation of LD recently developed as a self-administered treatment for OFF periods. Herein, the pharmacodynamic and pharmacokinetic properties, efficacy, and safety of CVT-301 are reviewed.

Expert opinion: CVT-301 may offer several potential advantages including increased systemic bioavailability through pulmonary absorption, rapid onset of action, avoidance of first-pass drug metabolism, and less plasma level variability. It should be noted that the delivery device used has been described as relatively simple to use, but the few steps required to prepare and self-administer the dose can be challenging for PD patients during their OFF state. Additionally, resolution of an OFF episode requires the administration of two capsules of CVT-301, which further complicates the use of the device.

KEYWORDS:

• Levodopa
• Parkinson’s disease
• CVT-301
• motor fluctuations
• ON-OFF
• dyskinesia
• inhalable levodopa

Article highlights

• CVT-301 is a dry powder aerosol, inhaled formulation of LD that is being developed as a self-administered rescue therapy for unpredictable and unresponsive OFF periods.

• CVT-301, due to its pulmonary route of absorption and avoidance of GI tract, provides a more rapid, reliable and consistent delivery of LD, which translates in a rapid and reliable increase in LD plasma levels.

• Clinical trials performed on fluctuating PD patients have showed that CVT-301, self-administered during OFF episodes, is able to provide a rapid improvement of motor function, and to significantly reduce daily OFF time.

• CVT-301 is generally safe and well-tolerated and its long-term use does not alter the natural progression of pulmonary function in advanced PD patients.

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Declaration of interest

M Torti and L Vacca have provided consultation to Zambon, UCB and Chiesi Farmaceutici while F Stocchi has provided consultation to Zambon, UCB, Chiesi Farmaceutici, Lundbeck, Sunovion, Bial, SynAgile, Biogen Idec, Kiowa and Impax. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This manuscript has not been funded.