In­tel­liPhar­maCeu­tics com­pletes part of Oxy­codone study

Stockwatch Daily - - HEALTH CARE - Mr. An­drew Pa­tient re­ports

IN­TEL­LIPHAR­MACEU­TICS IN­TER­NA­TIONAL Inc. has com­pleted the clin­i­cal part of its Cat­e­gory 2 and 3 hu­man abuse li­a­bil­ity stud­ies for its Oxy­codone ER (oxy­codone hy­drochlo­ride ex­tended-re­lease for­mu­la­tion) prod­uct can­di­date to sup­port its abuse-de­ter­rent la­bel claims for both the oral and in­tranasal route of ad­min­is­tra­tion.

The com­pany’s new drug ap­pli­ca­tion for an abuse-de­ter­rent ver­sion of Oxy­codone ER was ac­cepted for fil­ing by the U.S. Food and Drug Ad­min­is­tra­tion in Fe­bru­ary, 2017. The sub­mis­sion was sup­ported by Cat­e­gory 1 abuse-de­ter­rent stud­ies (to sup­port in­tra­venous abuse-de­ter­rent la­bel claim) and piv­otal phar­ma­coki­netic stud­ies that demon­strated that the prod­uct is bioe­quiv­a­lent to OxyCon­tin (oxy­codone hy­drochlo­ride ex­tended re­lease) and can be ad­min­is­tered with or with­out a meal (that is, no food ef­fect). A joint meet­ing of the anes­thetic and anal­gesic drug prod­ucts ad­vi­sory com­mit­tee and drug safety and risk man­age­ment ad­vi­sory com­mit­tee of the FDA, held in July, 2017, ex­pressed a de­sire to re­view ad­di­tional data for Oxy­codone ER that may be ob­tained from hu­man abuse po­ten­tial stud­ies for the oral and in­tranasal routes of ad­min­is­tra­tion.

The abuse li­a­bil­ity stud­ies for the in­tranasal route of abuse com­menced in May, 2018, with sub­ject screen­ing, while the stud­ies to sup­port abuse-de­ter­rent la­bel claims for the oral route of abuse com­menced in June, 2018. The clin­i­cal part of both stud­ies has now been com­pleted. Bio­an­a­lyt­i­cal sam­ples and sta­tis­ti­cal anal­y­sis for such stud­ies are pend­ing. An up­date on the re­sults will be pro­vided once the anal­y­sis is com­plete.

The FDA granted the com­pany’s re­quest for an ex­ten­sion to Feb. 28, 2019, to re­sub­mit the com­pany’s NDA for Oxy­codone ER un­der Sec­tion 505(b)(2) of the U.S. Fed­eral Food, Drug and Cos­metic Act. How­ever, the com­pany plans to re­sub­mit the ap­pli­ca­tion later this year.

There can be no as­sur­ance that In­tel­liPhar­maCeu­tics will not be re­quired to con­duct fur­ther stud­ies for Oxy­codone ER, that the FDA will ap­prove any of the com­pany’s re­quested abuse-de­ter­rent la­bel claims or that the FDA will ul­ti­mately ap­prove the NDA for the sale of Oxy­codone ER in the U.S. mar­ket, or that it will ever be com­mer­cial­ized.

About In­tel­liPhar­maCeu­tics In­ter­na­tional Inc.

In­tel­liPhar­maCeu­tics is a phar­ma­ceu­ti­cal com­pany spe­cial­iz­ing in the re­search, de­vel­op­ment and man­u­fac­ture of novel and generic con­trolled-re­lease and tar­geted-re­lease oral solid dosage drugs. The com­pany’s patented Hyper­ma­trix tech­nol­ogy is a mul­ti­di­men­sional con­trolled-re­lease drug de­liv­ery plat­form that can be ap­plied to a wide range of ex­ist­ing and new phar­ma­ceu­ti­cals. In­tel­liPhar­maCeu­tics has de­vel­oped sev­eral drug de­liv­ery sys­tems based on this tech­nol­ogy plat­form, with a pipe­line of prod­ucts (some of which have re­ceived FDA ap­proval) in var­i­ous stages of de­vel­op­ment. The com­pany has ab­bre­vi­ated new drug ap­pli­ca­tion and NDA 505(b)(2) drug prod­uct can­di­dates in its de­vel­op­ment pipe­line.

We seek Safe Har­bor.

Shawn Gra­ham, Ken­neth Keirstead, Ba­hadur Mad­hani, Amina Odidi, Isa Odidi, El­don Ray­mond Smith

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