Synergy Pharmaceuticals

Synergy Pharmaceuticals Inc is a global company headquartered in the United States and Australia.

History

Synergy Pharmaceuticals was founded in 2007. The company's global research operations, called "Synergy Medical Research (SMR)" have their global headquarters in Australia.

Intellectual property

Synergy produces a drug called Trulance, or plecanatide, which is used to treat irritable bowl treatment and constipation.[1] Three new patents for method of manufacturing, formulations, and methods of using Plecanatide were issued by the USPTO. Patents for Plecanatide have also been issued by the European Patent Office (EPO).[2]

Plecanatide

Synergy filed an investigational new drug (IND) application to the US FDA on April 2, 2008, and by May 2, 2008 had received notice that its proposed study was safe.[3] The first Phase I clinical trial for Plecanatide (formerly proprietary drug SP-304) began in June 2008. Beginning in February 2010, multiple Phase II clinical trials were initiated, including the CIC3 and National CIC3 trials. The latest Phase II trial for CIC concluded in March 2016.[4] There have also been multiple Phase III trials for Plecanatide in its pursuit of an IBS-C indication, the latest of which was completed in June 2017.[5]

References

  1. "Trulance - FDA prescribing information, side effects and uses". Drugs.com. Retrieved 2020-05-16.
  2. "Ironwood Lied To Patent Offices: $500M Suit - Law360". Law 360. Retrieved 2020-06-30.
  3. "Pawfect Foods, Inc. (July 21, 2008)". Securities and Exchange Commission. Retrieved 2020-05-16.
  4. "Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC) - Full Text View - ClinicalTrials.gov". U.S. National Library of Medicine. Retrieved 2020-05-16.
  5. "Long Term Safety Study of Plecanatide - Full Text View - ClinicalTrials.gov". U.S. National Library of Medicine. Retrieved 2020-05-16.
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