Cysteamine

DR Cysteamine is designed for reduced dose frequency and improved tolerability, compared to immediate-release cysteamine, which is the current standard of care in cystinosis.

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For some background, on June 6, the company announced that on June 3 the last clinical trial patient visits were completed and final data analysis will commence this week on the Phase 3 clinical trial of its delayed-release oral formulation of DR Cysteamine in patients with cystinosis.

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Raptor's clinical programs include DR Cysteamine for the potential treatment of nephropathic cystinosis, non-alcoholic steatohepatitis "NASH", and Huntington's Disease.

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The data was statistically significant and demonstrated that DR Cysteamine RP103 was non-inferior and assessed the steady-state white blood cell cystine levels of RP103 compared to Cystagon.

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The pivotal Phase 3 clinical trial is designed as an outpatient study of the safety, tolerability, pharmacokinetics ("PK") and pharmacodynamics ("PD") of every 12-hour DR Cysteamine compared to every 6-hour immediate-release cysteamine bitartrate in cystinosis patients.

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The extension phase of the clinical trial, in which all patients completing the Phase 3 study may elect to continue on DR Cysteamine therapy, is ongoing.

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DR Cysteamine is Raptor's proprietary enteric-coated, microbead oral formulation of cysteamine bitartrate designed to potentially reduce dosing frequency and reduce gastrointestinal side effects associated with immediate-release cysteamine bitartrate, which is approved for sale by the FDA and European Medicines Agency to treat nephropathic cystinosis.

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RPTP pivotal Phase 3 clinical trial of DR Cysteamine for the potential treatment of nephropathic cystinosis are expected by the end of July.

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This unique application and gentle formula contains no Thio, and utilizes natural Cysteamine, a natural amino acid, to realign the hair's internal bonds to create a soft sensuous wave.

WN.com - Articles related to Medical-marijuana advocates seeking society's approval 2010

This unique application and gentle formula contains no Thio, and utilizes natural Cysteamine, a natural amino acid, to realign the hair's internal bonds to create a soft sensuous wave.

WN.com - Articles related to Medical-marijuana advocates seeking society's approval 2010