=IntelliPharmaCeutics (IPCI) – FDA raises concerns over opioid med Rexista

A Food and Drug Administration advisory committee will review IntelliPharmaceuticals International Inc.'s (IPCI) tamper resistant opioid painkiller Wednesday, July 26 and Purdue Pharma LP will be a very interested observer.

A 13-member committee will examine Rexista, a long-acting opioid-based pain med from Toronto-based IntelliPharmaceuticals that has been formulated to be tamper resistant. The drug contains a blue dye which would mark those who tampered with the drug. It also contains a nasal irritant designed to keep the drug from being easily inhaled.


FDA’s Rexista Concern

The FDA’s action stems from growing concerns over a wave of opioid abuse and overdoses that are becoming a national healthcare crisis. Most of these treatments normally treat chronic pain that persists even with the application of other forms of therapy. The agency is now requiring the likes of IntelliPharmaCeutics Intl Inc. (USA) (NASDAQ:IPCI) to prove their drugs are designed to discourage abuse.

Rexista is developed as an abuse-deterrent version of Purdue Pharma’s OxyContin which also boasts of tamper resistance properties. The opioid contains a blue dye that is emitted whenever the tablet is tampered with or crushed

Q2 Earnings Report

Separately, IntelliPharmaCeutics Intl Inc. (USA) (NASDAQ:IPCI) reported a second quarter net loss of (-$1.8) million compared to a net loss of (-$2) million reported last year. A decrease in net loss, according to the company, was due to an increase in licensing revenues from the sales of generic Focalin XE.

Revenues in the quarter more than tripled to highs of $2 million from $0.6 million reported for the corresponding period last year. The increase was primarily due to the launch of generic Focalin XR capsules.

Research & Development expenditure was up by $1.2 million compared to last year, attributed to higher stock compensation expense. Selling & General Expenses dropped to $0.8 million from $0.9 million due to a decrease in professional fees and wages.

Intellipharmaceutics Warning

During the quarter, IntelliPharmaCeutics Intl Inc. (USA) (NASDAQ:IPCI) secured FDA approval for all strengths of Seroquel. However, the company has warned that there are no assurances that the product will generate significant revenues.