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April 17, 2014
07:06 EDTATRSAntares Pharma says ARD publishes results from OTREXUP study
Antares Pharma announced that the Annals of the Rheumatic Diseases has published results from an open-label, head-to-head randomized, crossover study comparing the relative bioavailability, safety and tolerability of OTREXUP to oral methotrexate in adult patients with rheumatoid arthritis. In this multicenter, three-way crossover study, patients greater than or equal to 18 years old with adult RA undergoing treatment with MTX for three months or more were assigned to receive one of four dose levels of OTREXUP, 10 mg, 15 mg, 20 mg, and 25 mg weekly in a random sequence of three treatments: oral, subcutaneous into the abdomen and subcutaneous into the thigh. For 24 hours after the administration of each treatment, blood samples were collected to measure drug levels and injection sites were assessed. Forty-seven patients completed the study and the results showed that the systemic availability of methotrexate following oral dosing plateaus at 15 mg and greater. Following administration of OTREXUP, the systemic availability increased proportionally at every dose, which extended the range of exposure compared to patients receiving oral therapy. No unexpected adverse events were noted for either formulation in this short term study and higher systemic MTX exposure was not associated with increases in adverse events.
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March 4, 2015
09:07 EDTATRSFDA making testosterone product makers change labeling
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February 25, 2015
07:12 EDTATRSAntares Pharma announces QuickShot testosterone study met primary endpoint
Antares Pharma announced positive top-line pharmacokinetic results that showed that the primary endpoint was achieved in the company’s ongoing, multi-center, phase 3 clinical study evaluating the efficacy and safety of testosterone enanthate administered once-weekly by subcutaneous injection using the QuickShot auto injector in testosterone deficient adult males. In the study, 150 adult males with hypogonadism low testosterone and testosterone blood levels less than 300 ng/dL received a starting dose of 75 mg of subcutaneously administered testosterone enanthate once weekly for six weeks. Blinded adjustments to dose were made when necessary at week seven based upon the week six pre-dose blood level, and full pharmacokinetic profiles were obtained during the 12th week of treatment. One hundred fifty patients have received at least one dose of study drug and to date, there have been no reported deaths and one serious adverse event of hospitalization for worsening depression. This patient received a single dose of QS T, and the SAE was not considered to be related to study drug. Thus far, there have been no reported adverse events consistent with urticaria. The FDA has recommended that the company create a larger safety database, including approximately 350 subjects exposed to QS T with 200 subjects exposed for six months and 100 subjects exposed for a year. Based on the number of subjects in previous studies and in the current phase 3 study, the company anticipates that it may need approximately 70 additional subjects exposed to QS T for six months.

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