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Mucoadhasive buccal extended release tablet for Parkinson late motor complications treatment

Parkinson Late motor complication

Late motor complocations problem

Patients affected by Parkinson’s disease (PD) suffer from dopamine deficiency in specific brain regions. Symptomatic benefit is achieved by giving the patients drugs that provide dopamine, or that mimic the action of dopamine in the brain. In advanced stages of the disease, patients suffer from On-Off fluctuations (late motor complications), which can be overcome by a continuous dopaminergic stimulation. To date, best continuous dopaminergic stimulation is achieved by delivering L-DOPA, using an invasive and inconvenient device

Existing technologies

All the existing technologies aimed at treating late motor complications in PD based on providing continuous dopaminergic stimulation (CDS) and currently all of them are either invasive or use multiple injections.                      

  • Deep Brain Stimulation (DBS), which constitutes electrodes inserted to the brain, does not fit to all PD patients and it requires surgery.
  • Subcutaneous administration of L-DOPA/Carbidopa or of Apomorphine is done by prolonged injections, which are inconvenient for the patients and cause skin irritation.
  • Duodopa, a device that provides L-DOPA/Carbidopa continuously to the duodenum, is an invasive device, requiring surgery for its application. In order to benefit from the Duodopa treatment, there is a need to insert a PEG through gastroscopy. This fact causes concern among various patients.  

Mucoadhasive buccal extended release tablet for Parkinson's Late Motor Complications treratment

Lasting Effect Consumer Pharma Ltd. developed a buccal mucoadhasive tablet, capable of releasing hydrophilic and lipophilic drugs in a linear manner during up to 6 hours. Lasting Effect’s tablets are aimed to be used for a variety of medical indications, where continuous delivery of the treating drug is needed.                                                                  

Lasting Effect’s solution is a buccal mucaodhasive extended release tablet that sticks within the oral cavity and releases continuously a highly effective dopaminergic compound, which is absorbed via the oral mucosa, inducing continuous dopaminergic stimulation in a non-invasive manner.

Continuous dopaminergic stimulation has been shown to be effective in alleviating late motor complications in Parkinson’s disease

Lasting Effect proof of concept studies showed the capability of the tablet to release the API continuously in a linear fashion, producing therapeutic concentrations in the saliva during the entire delivery period (up to 6 hours)

Key Features

  • Extended Duration: 6 hours of sustained therapeutic drug delivery
  • Regulatory Pathway: 505(b)(2) FDA route, leveraging existing safety databases for approved APIs
  • Development Stage: Preclinical pharmacokinetic and safety evaluation phase
  • Mechanism of Action:
    • Bypasses hepatic first-pass metabolism via buccal absorption
    • Provides steady-state plasma concentrations without peak-trough oscillations
    • Enables rapid dose titration and predictable pharmacokinetics
  • Therapeutic Advantages:
    • Reduces motor fluctuation severity and frequency
    • Minimizes peripheral dopaminergic side effects (nausea, hypotension)
    • Ideal for patients with dysphagia or gastroparesis
    • Compatible with existing apomorphine sublingual immediate release buccal tablet

 

 

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