NeuroDerm issued a new US patent for aqueous apomorphine covering concentrated subcutaneously delivered pharmaceutical compositions
Company's ND0701 formulation intended for chronic therapy of Parkinson's disease and is developed for continuous subcutaneous administration by a small, low-volume, disposable patch-pump.
NeuroDerm has announced that the US Patent and Trademark Office has issued US Patent No. 9,381,249, which claims aqueous pharmaceutical compositions comprising apomorphine, and relates to the company’s ND0701 program. ND0701's formulation, containing concentrated apomorphine-base, is intended for chronic therapy of Parkinson's disease and is developed for continuous subcutaneous administration by a small, low-volume, disposable patch-pump. ND0701 has been shown in pre-clinical studies to have better local tolerability than commercially available, continuous, subcutaneously administered apomorphine-HCl. NeuroDerm is currently conducting a bioequivalence trial in the EU (Trial 101) comparing ND0701 with commercially available continuous, subcutaneously delivered apomorphine-HCl in its pursuit of a regulatory development route in the EU based on bioequivalence. The patent has an expiration date of 2033.
“ND0701 is an innovative, proprietary, concentrated apomorphine-base formulation resulting from NeuroDerm’s expertise in formulation chemistry,” said Oded S. Lieberman, NeuroDerm’s CEO. “This patent demonstrates our capabilities in developing novel, pharmaceutical formulations designed to enable and/or improve therapies for central nervous system diseases by continuous, subcutaneous drug administration. With the recently initiated ND0701 bioequivalence trial and potential to pursue an abbreviated regulatory pathway in the EU, we believe our novel formulation, designed for delivery by a small, convenient patch-pump, may be able to bring to Parkinson’s disease patients a much needed new treatment option.”
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