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PHN131 (Treat moderate to severe pain)

Nalbuphine, a semi-synthetic opioid, is a kappa agonist/partial mu antagonist, which can be used to induce balanced anesthesia. Its analgesic effect works in essentially the same way as morphine. The onset of action is approximately 2-3 minutes after intravenous administration, while the onset of action after subcutaneous or intramuscular injection is less than 15 minutes. Its plasma half-life is 5 hours and the duration of its analgesic activity was found to be between 3 and 6 hours during clinical studies.

PhytoHealth PHN131 utilized a patented technology to improve the oral bioavailability (BA) of nalbuphine. This patented technology uses an oral formulation, which inhibits the first-pass metabolism of nalbuphine, by using excipients of other known safe compounds to inhibit enzymes, thereby improving the intestinal and hepatic BA.

Nalbuphine, the principle component of PHN131, is currently sold in the market in injection form. By applying novel and patented technology, PHN131 is developed as an orally administrated medicine, and used to improve the weak analgesic effects of direct oral administration of the principal component. PhytoHealth PHN131 was developed to present an analgesic effect similar to that of morphine, with easy administration and a broadened scope of application, as well as improved effectiveness when compared to other orally administered analgesics.

Currently, pivotal trials of PhytoHealth PHN131 have been completed in the Tri-Service General Hospital, Taipei Veterans General Hospital, Cheng Hsin General Hospital, and Taipei Tzu Chi Hospital. The technology used in PhytoHealth PHN131 has received patent approval in the United States, Taiwan, mainland China, Japan, and Canada.


Notable achievements

01

Receiving the grants of the Leading new product development plan for the industrial Development Bureau, Ministry of Economic Affairs in 2009

02

【PNH131】was awarded the 2009 Taipei Biotech Award in Industry Cooperation category

03

【PNH131】was awarded 7th National Innovation Award

04

TFDA agree to proceed the phase I clinical trials in 201

05

TFDA agree to proceed the pivotal clinical trial in 2013

06

The US,China,Canada,Japan and Taiwan Patents have been approved

07

The PHN131’s pivotal clinical trial had been completed on March 2016 and the data unblended to demonstrate positive result.