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Shares of Intellipharmaceutics International (TSX:I) (NASDAQ:IPCI) soared 19.34% after the company said it would speed up development of its Rexista (TM) Oxycondone XR (Abuse deterrent oxycondone hydrochloride) extended release tablets after the US Food and Drug Administration (FDA) said the company can avoid Phase III testing should it prove bioequivalence to Oxycontin.
Not only has the FDA’s decision facilitated Rexista’s development it has also made it cheaper because Phase III studies are as time consuming as they are costly:
“The FDA's positive acknowledgement…enables us to accelerate the development and commercialization of our abuse deterrent Rexista (TM) Oxycodone XR product candidate. The avoidance of a Phase III trial eliminates a significant financial hurdle. More importantly it shortens the development timeline and potential time to market" said stated Intellipharmaceutics’ CEO and co-founder Dr. Isa Odidi.
The company expects to file A New Drug Application (NDA) for Rexista with the FDA within the next 6 to 12 months though a company statement warns that it gives no assurances that the FDA will approve the NDA for the actual commercialization of Rexista in the U.S. market.
Oxycodone is a narcotic analgesic very potent derivative of Thebaine and belongs to the family of opioids. It is prescribed to relieve moderate to severe pain.
Pregabalin known by the brand name Lyrica is an analgesic anticonvulsant and anxiolytic drug that has been marketed in Canada since July 2005. Pregabalin is prescribed to adults for the treatment of neuropathic pain associated with diabetes post-herpetic neuralgia (following a shingles) and pain associated with fibromyalgia.
Oxycodone can be abused because of its morphine like qualities. The medication has acquired a stigma which has sometimes led to legitimate patients avoiding it faring addiction. Some doctors do not even prescribe it for fear of prosecution given law enforcement crackdowns on brand name variants such as OxyContin.
Toronto-based Intellipharmaceutics makes generic controlled-released and targeted release oral solid dosage drugs based on the Company's patented Hypermatrix technology which is a controlled-release drug delivery platform with applications in a wide range of existing and new pharmaceuticals. The company has a pipeline of products in various stages of development in therapeutic areas which include neurology cardiovascular gastrointestinal tract pain and infection.
Intellipharmaceutics’ formulation intends to offer a barrier to the tampering of oxycodone “when subjected to various forms of anticipated physical and chemical manipulation commonly used by abusers.” The company says that its preparation also prevents dose dumping when inadvertently co-administered with alcohol.
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