Friday, January 25, 2013

USFDA Approves GI safe Aspirin

Recently the USFDA approved a new formulation (PL2200) of wiidely prescribed NSAID drug Aspirin that is expected to offer better GI safety. The new formulation has been developed by PLX Pharma.  The USFDA approval has come on back on clinical trials which demonstrtaed superior safety profile of the novel formulation develoed by PLX Pharma's aspirin. Lee Pharma has inlicensed rights for PL2200 for China.

PL 2200 Aspirin is a novel immediate-release investigational product containing 325 mg aspirin. In clinical trials, PL2200 demonstrated a 71.0% reduction in the incidence of gastric and duodenal ulcers (p=0.0069) and a 47.4% lower incidence of combined erosions and ulcers (p=0.0025) for a once-a-day dose of PL 2200 Aspirin as compared to immediate-release over-the-counter aspirin, following administration for 7 days.

About PLX Pharma
PLx is a pharmaceutical company developing GI safer formulations of proven non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin and ibuprofen for prescription and over-the-counter markets. PLx has created novel NSAID formulations, using the PLxGuard™ technology, which have the potential to reduce the serious and common gastrointestinal side- effects caused by virtually all NSAIDs

About PLxGuard™ technology

Non-Steroidal Anti-Inflammatory Drug ProductsDr. Lenard Lichtenberger, the scientific founder of PLx Pharma, has identified a key mechanism by which NSAIDs cause such GI damage: they disrupt the normal barrier to acid by interacting with components of the GI lining, most notably a component called phosphatidylcholine (PC). When NSAIDs are taken, they bind to the PC in the GI lining and compromise the lining’s acid-repelling properties. Over time, the disruption of the GI lining can lead to clinically significant—and sometimes life-threatening—damage, such as ulceration, bleeding and perforation.

Exploiting this insight, PLx has created formulations of the most commonly taken NSAIDs, in which the NSAID is pre-associated with PC; this is the PLxGuard™ technology.. This NSAID-PC pre-association effectively sequesters the NSAID in a phospholipid envelope, allowing the NSAID to reach the blood stream without disrupting the GI lining. This technology allows the same effective dose of the NSAID to reach its site of action in the body, while significantly reducing the chances of GI damage. Importantly, the phosphatidylcholine that PLx uses in its formulations is a non-pharmaceutical natural product derived from soybeans. Phosphatidylcholine occurs naturally in the diet and has long been used as a food additive and nutraceutical.


PLx Product Pipeline — with PLxGuard™

Oral Rx NSAID ProductsIndicationDescription
Zavryl™
PL1100 Ibuprofen (400 mg)
ArthritisClinical development
PL4100 IndomethacinGoutPreclinical development
PL5100 Diclofenac ArthritisPreclinical development
MeloxicamArthritisPreclinical development
PiroxicamArthritisPreclinical development
Oral OTC NSAID ProductsIndication 
Zavryl™
PL1200 Ibuprofen (200 mg)
Pain/FeverClinical development
PL2200 Aspirin (325 mg)Cardio prevention
Pain/Fever
Cancer Prevention
Clinical development
IV Products  
PL4500 Indomethacin IVPain
Pediatric (PDA)
Preclinical development
Ketorolac IVPainPreclinical development
Diclofenac IVPainPreclinical development
Non-NSAID Products
PL9100 5-ASAOut LicensedOut Licensed





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