Biotech Values

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JAV:
New Study Shows Javelin Pharmaceutical's DylojectTM Well-Tolerated in High-Risk Patients with Impaired Renal and Hepatic Function

(The interest in JAV has dwindled to almost nil here. Today's PK reseults are positive but beg the question regarding where the anticipated Ereska (inhalable ketamine) P3 results are. Y3maxx is now touting a conspiracy that mgmt is withholding the Ereska results until after the 6/23 annual shareholders' meeting so mgmt can lock in a new round of options at the lowest possible price. aj)

http://finance.yahoo.com/news/New-Study-Shows-Javelin-bw-15523708.html?.v=1

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV - News) today reported encouraging findings from a new Phase I pharmacokinetic (PK) and safety study of Dyloject in patients with mild to moderate renal and mild hepatic impairment. Dyloject was well tolerated in these higher risk patient populations. The elimination rate of Dyloject's active ingredient diclofenac was statistically indistinguishable in all three patient groups compared with matched healthy controls. The Company plans to file a New Drug application for Dyloject in the United States during the fall of 2009, at the same dose used in these studies.

“Historically, IV nonsteroidal anti-inflammatory drugs (NSAIDs) such as ketorolac, the only IV NSAID approved in the US for moderate to severe pain, have been withheld from such patient populations or required major dose reductions because of concern for adverse effects” stated Daniel Carr, M.D., Javelin’s President and Chief Medical Officer. “Dyloject’s excellent tolerability in all study groups, and the insignificant changes in diclofenac distribution and clearance observed in patients with mild to moderate chronic renal insufficiency or mild hepatic impairment are most encouraging. These new PK and safety findings will be included in our NDA filing for Dyloject.”

About The Study:

This Phase I, open-label, single-dose study evaluated the safety and pharmacokinetics of Dyloject 37.5 mg given as an IV bolus over 15 seconds in subjects with mild or moderate chronic renal insufficiency and with mild chronic hepatic impairment compared to matched healthy adult volunteers. Additionally, healthy adult volunteers participated in a randomized, open-label, crossover study in which they received a single dose of Sporanox® (itraconazole 200 mg with 8 gm of the solubilizing agent HPβCD) given as an IV infusion over 60 minutes to compare the PK and safety of HPβCD in the two medications. The 37.5 mg dose of Dyloject is formulated with 0.3 gm of HPβCD. A total of 40 subjects were treated in this study including 13 patients with mild to moderate renal insufficiency (creatinine clearance 30-80 ml/min), 8 patients with mild hepatic impairment and 19 healthy adult volunteers. Patients continued to take their prescribed medications to treat hypertension, diabetes and high cholesterol.