About DopaFuse

  • Designed for Parkinson's Disease patients
  • Provides continuous delivery of levodopa
  • May provide more stable drug levels in the blood, potentially reducing "Off" time
  • Uses the OraFuse platform

About OraFuse®

  • OraFuse is SynAgile's proprietary technology for continuous drug delivery in the mouth
  • Can be used for numerous drugs

OraFuse Technology:
A novel, non-invasive method of drug delivery in the mouth

Drug Types

Orally-delivered drugs, including:

Narrow therapeutic index drugs.
Drugs that cannot be formulated for extended release



Buccally-delivered drugs



Topical drugs for the mouth, pharynx, and esophagus

Benefits



More stable plasma drug concentrations. Fewer dose-related side effects.

Allows buccal delivery of drugs requiring frequent or continuous dosing, rather than just drugs requiring episodic dosing.

Allows topical delivery of drugs requiring frequent or continuous dosing to the mouth, pharynx and esophagus.

Phase 2 Clinical Trial

SynAgile is currently conducting a Phase 2 clinical trial on the DopaFuse Delivery System titled “Study of Continuous Oral Levodopa” (SCOL) in order to study the safety and efficacy of DopaFuse. The SCOL study is enrolling 24 patients in Italy, Luxembourg, and Spain.

Founders

SynAgile was founded by highly successful serial inventor-entrepreneurs Adam Heller (CSO) and Ephraim Heller (CEO). The father-son team have over 300 patents (most in use) and a track record which includes the founding of AngioScore (sold for $235 million) and TheraSense (which went public and was later sold for $1.2 billion). Adam Heller is also a coinventor of the first commercialized lithium thionyl chloride battery and a recipient of the US National Medal of Technology and Innovation, the highest technology honor in the United States.

The SynAgile founding team began developing OraFuse after seeing an opportunity to improve patients’ quality of life via a new class of drug delivery devices.

News

First Patient Treated with the DopaFuse Delivery System

October 27th, 2021

SynAgile is pleased to announce treatment of the first patient with the DopaFuse Delivery System in the SCOL (Study of Continuous Oral Levodopa) clinical trial. The patient was treated at the Luxembourg Institute of Health and the Centre Hospitalier de...

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Advancing the Treatment of Parkinson’s Disease

September 30th, 2021

The Luxembourg Institute of Health (LIH) and the Centre Hospitalier de Luxembourg (CHL) announce the launch of “SCOL” (Study of Continuous Oral Levodopa), a unique international clinical trial aiming to assess the safety, tolerability and...

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SynAgile Takes On Debt to Wrap Up Midphase Trial of Drug Delivery Dental Retainer

September 28th, 2021

The limitations of orally delivered levodopa have inspired a range of novel formulations designed to provide more constant levels of the drug. SynAgile has put its own spin...

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Federal law limits the use of DopaFuse to Investigational Use Only. DopaFuse is not available for sale.