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FDA Gives Phase III Nod to Intec Parkinson’s Treatment

Intec Pharma says it expects the Phase III trial for its Accordion Pill Levodopa to take place in the second half of 2015.


Giora Carni picture Eyal Yitzhar

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Intec Pharma Ltd. (TASE: INTP) reported today that it had received US Food and Drug Administration (FDA) approval for carrying out a Phase III trial of its Accordion Pill Levodopa for the treatment of Parkinson’s Disease. The Accordion Pill is a gastro-retentive drug delivery system.

Intec says that it will conduct discussions with the FDA on the protocol for the trial. The company estimates that the trial, whether carried out independently or in collaboration with a leading pharmaceuticals company, will take place in the second half of 2015.

Intec chairman Zvi Joseph said, “We are very proud and happy that the FDA has given us approval for entering into a Phase III trial for the Accordion Pill Levodopa that Intec Pharma has developed. The clinical effect obtained to date, together with the high safety profile demonstrated in all the trials, indicate the potential of Accordion Pill Levodopa to become a leading treatment for Parkinson’s.”
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