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Archimedes Pharma Announces Successful Proof-of-Concept Results on Two Intranasal Development Projects
Date:2/26/2009

ed Parkinson's disease. Presently, apomorphine is administered by intermittent SC injection usually via a pre-filled autoinjector pen, or by continuous (waking day or round the clock) SC infusion. Drawbacks associated with SC therapy for patients and carers include the need for multiple injections, which can be painful and are often associated with the development of troublesome nodules at the injection site, and the requirement for a degree of manual dexterity that some PD patients find difficult. IN Apomorphine, an innovative aqueous nasal spray formulation has been designed to counter these issues by offering improvements in convenience and acceptability to both patients and physicians combined with ease/speed of use and rapid onset of action. Archimedes' unique formulation is based on enhanced solubility providing a stable, high strength solution, allowing a wide range of doses to be administered in a small spray volume using conventional, approved nasal spray devices.

Archimedes estimates that there around 1.3 million Parkinson's disease patients in the US and Europe, of which around 250,000 suffer from acute "off" episodes.

IN Diazepam - trial design, results and development rationale

A Phase I study in 12 healthy adult volunteers was conducted to assess the bioavailability, PK and safety/tolerability of a single 5 mg dose of Archimedes' IN Diazepam compared to commercially available intravenous (IV) and rectal formulations (2 mg and 5 mg doses respectively). Diazepam was extensively and rapidly absorbed from the IN product and demonstrated an enhanced bioavailability compared to the commercial rectal formulation, with maximum plasma concentrations achieved in approximately 15 minutes. The product was well tolerated and no clinically significant safety issues were reported. Rapid and reproducible delivery via the nasal route illustrates the potential of IN Diazepam to replace IV and rectal produ
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SOURCE Archimedes Pharma Limited
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