Acelrx Pharmaceuticals Inc., of Redwood City, Calif., reported top-line data that showed its sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System met the primary and secondary efficacy endpoints in a placebo-controlled, Phase III study. In the 48 hours following major orthopedic surgery, patients treated with sufentanil NanoTabs realized a significantly greater score in the Summed Pain Intensity Difference (SPID) than placebo-treated patients. Secondary endpoint data showed

Ltd., of Tokyo, and H. Lundbeck A/S, of Copenhagen, Denmark, reported results from a preliminary analysis showing statistically significant reductions (p < 0.0001) in total psychiatric hospitalization rates in patients diagnosed with schizophrenia who were converted to once-monthly Abilify Maintena, an extended-release version of aripiprazole, compared to previous treatment with daily standard-of-care oral antipsychotics

Abbvie Inc., of Chicago, initiated a Phase III study called SONAR (Study Of Diabetic Nephropathy with Atrasentan) to assess the effects of the investigational compound atrasentan, when added to standard of care, on progression of kidney disease in patients with stage 2 to 4 chronic kidney disease (CKD) and Type II diabetes

In Phase II, efficacy of the drug in combination with standard of care cisplatin or etoposide will be compared to placebo with cisplatin or etoposide

the results compared favorably to the PFS reported with the standard of care of radiation and temozolomide alone, which is 6.9 months

The open-label trial will evaluate efficacy, safety and tolerability at two sites in France, enrolling up to 32 HCV-infected patients of any genotype who previously failed or relapsed following standard-of-care treatment

The study will have three arms of 211 patients each and will test a 0.03 percent formulation of the drug against a topical vehicle and against a standard-of-care hydrogel

aerosolized placebo in the treatment of intubated and mechanically ventilated patients with Gram-negative pneumonia receiving standard-of-care intravenous antibiotics

The SIRFLOX study aims to evaluate whether a first-line treatment strategy of standard-of-care chemotherapy plus SIR-Spheres microspheres is more effective in delaying cancer progression than chemotherapy alone, in patients with inoperable liver metastases from primary colorectal cancer

Patients additionally received optimal standard-of-care treatment

standard of care alone in 200 patients with alcohol-induced liver decompensation

Acasti also observed a trend indicating a dose-response relationship compared to standard of care, as well as statistically significant effects from doubling the doses of CaPre

The study enrolled 56 patients with newly diagnosed primary brain cancer (glioblastoma multiforme) and is designed to determine whether adding TSC to the current standard of care can significantly improve survival

The open-label trial will evaluate the efficacy, safety and tolerability of the drug in patients infected with HCV, of any genotype, who have previously failed or relapsed following standard-of-care treatment

The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer to demonstrate a statistically significant 10 percent improvement in overall survival of enrolled patients who are treated with Multikine plus Standard of Care (SOC) vs

EB-1020 is being developed to improve efficacy compared to existing non-stimulants, but to do so with less risk of abuse liability and diversion, or non-medicinal use, than the current stimulants (amphetamine and amphetamine-like medications) that are the standard of care in ADHD

The drug is designed to slow progression of kidney damage and be additive to the current standard of care, which is treatment with an angiotensin converting enzyme inhibitor and/or an angiotensin receptor blocker

Biogen Idec Inc., of Weston, Mass., and Swedish Orphan Biovitrum, of Stockholm, Sweden, reported data confirming that investigational recombinant factor VIII Fc (rFVIIIFc) fusion protein and factor IX Fc (rFVIXc) fusion protein gave long-lasting protection from bleeding with fewer injections than the standard of care for hemophilia

In addition to standard-of-care treatment, the patients received several doses of the therapeutic vaccine, which targets the tumor vasculature, or placebo