Why IntelliPharmaCeutics Just Had A Big Tuesday
IntelliPharmaCeutics International Inc. (NASDAQ: IPCI) spiked Tuesday after the company obtained fast-track designation for its Rexista Oxycodone treatment designed to deter abuse.
The Ontario-based company said the designation from the U.S. Food and Drug Administration could potentially result in accelerated approval for the product.
IntelliPharma changed hands recently at $3.47, up nearly 12 percent. The shares hit a high of $3.92 earlier and are up more than 20 percent during the past five trading days.
Related Link: Intellipharmaceutics Is 'Not Just A Generic Drug Story,' Brean Capital Says
The company is developing a technology to overcome abuses associated with oxycodone and other opioid analgesics.
Last week IntelliPharma said regulators won't require it to conduct Phase III studies on Rexista Oxydontin if bioequivalence to Oxycontin is demonstrated.
Results of three definitive Phase I trials released in March all met the bioequivalence criteria, and IntelliPharma said it believes Phase III studies won't be required.
The product could, if successful, decrease the desirability of taking more tablets than prescribed, potentially resulting in fewer accidental or intentional deaths, according to the company.
"To the best of our knowledge, no other product currently approved for sale in the U.S. or Canada has demonstrated this potential," Chief Executive Isa Odidi said in a statement Tuesday.
Separately, on Tuesday, the company said it hasn't obtained final FDA approval for 5 milligram strength of its generic Focalin extended release treatment for attention deficit disorder.
Although IntelliPharma said it hadn't received any indication from the FDA of a deficiency in its application, it had "no further information" as to when or if final approval will be granted by the FDA for the generic Focalin.
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