Intellipharmaceutics International Inc. (IPCI)

[TRENDmendous]

For comparison: Similar paths

PTIE's Remoxy is like IPCI's Rexista

Pain Therapeutics received a CRL for their Remoxy ER on 9/26/16. http://investor.paintrials.com/releasedetail.cfm?ReleaseID=990817

On 3/20/17 they issued a press release that it would cost appoximately $3-4 million to perform additional studies for:

CLINICAL (INTRANASAL) ABUSE POTENTIAL STUDY
REMOXY has a sticky, high-viscosity gel formulation that cannot be snorted. Therefore, our intranasal study will ask human volunteers to self-administer into their nostrils REMOXY, placebo or an active comparator. Positive data in one intranasal study is adequate to support a label claim against the intranasal route of abuse. We previously generated positive results using REMOXY under similar test conditions in a large animal model.

NON-CLINICAL ABUSE POTENTIAL STUDY
REMOXY's sticky, high-viscosity formulation cannot be pulled through a normal size syringe. This feature makes it difficult to abuse REMOXY via simple injection. Therefore, we will conduct an abuse potential study in a lab using thin films of REMOXY smeared on glass plates to assess how household solvents affect the formulation. We plan to generate these data against comparator products. Positive data in this study is adequate to support a label claim against the injection route of abuse. We previously generated positive results using REMOXY under similar test conditions.

They are just now getting ready for resubmission in Q1 of 2018. http://investor.paintrials.com/releasedetail.cfm?ReleaseID=1045928

During this time they did a 7 for 1 reverse stock split. http://investor.paintrials.com/releasedetail.cfm?ReleaseID=1025282