Teflaro for Bacterial Infections
Ceftaroline fosamil (Teflaro, Forest), an injectable antibiotic, has been approved to treat adults with community- acquired bacterial pneumonia and acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus (MRSA).
Ceftaroline is a cephalosporin, which acts by interfering with the bacterial cell wall. The drug’s safety and effectiveness were evaluated in four phase 3 clinical trials in patients 18 years of age and older. Adverse effects included diarrhea, nausea, and rash.
Source: FDA, October 29, 2010
KL4, an Orphan Drug For Cystic Fibrosis
An orphan drug designation has been approved for Discovery’s KL4 surfactant for patients with cystic fibrosis (CF). CF is caused by a genetic mutation that can cause life-threatening lung infections and premature death. Previous studies had suggested that a surfactant might improve mucociliary clearance, perhaps with the potential to prevent further compromise of lung function.
Discovery completed a double-blind, randomized crossover phase 2a study in which the aerosol surfactant was generally safe and well tolerated. Patients experienced improved mucociliary clearance, and no associated serious adverse events were reported.
Source: Drug Discovery Dev, November 2, 2010
Latuda Benefits Adults With Schizophrenia
Lurasidone HCl tablets (Latuda, Sun- ovion) have been approved for the treatment of schizophrenia in adults. Like other atypical antipsychotic agents, lurasidone carries a boxed warning alerting prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older adults with dementia-related psychosis. Lurasidone is discussed in this month’s Pharmaceutical Approval Update on page 693.
Source: FDA, October 28, 2010
Egrifta Treats Lipodystrophy In HIV Infection
The FDA has approved tesamorelin injection (Egrifta, Theratechnologies, Inc./EMD Serono) to treat HIV patients with lipodystrophy. This condition, in which excess fat develops around the liver, stomach, and other abdominal organs, is associated with many antiretro- viral drugs.
Tesamorelin is a growth hormone- releasing factor that is administered once daily. In two clinical trials, patients receiving tesamorelin experienced greater reductions in abdominal fat, compared with patients receiving placebo. Some patients also reported an improved self- image.
Adverse effects included joint, stomach, and muscle pain; erythema and pruritus at the injection site; swelling; and worsening blood glucose control.
Source: FDA, November 10, 2010
Halaven for Breast Cancer
Eribulin mesylate (Halaven, Eisai) has been approved to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.
Eribulin, a microtubule inhibitor, is a synthetic form of a compound derived from the sea sponge Halichondria oka- dai. Before therapy, patients should have received prior anthracycline-based and taxane-based chemotherapy for early or late-stage breast cancer.
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In a randomized study of 762 women, median overall survival rates were 13.1 months with eribulin and 10.6 months with a different agent. Adverse effects included neutropenia, anemia, leuko- penia, hair loss, fatigue, nausea, peripheral neuropathy, and constipation.
Source: FDA, November 15, 2010
Gablofen for Spasticity
CNS Therapeutics has announced the FDA’s approval of Gablofen (baclofen) injection for use in the management of severe spasticity. This movement disorder affects more than 500,000 patients in the U.S. alone and is often brought on by multiple sclerosis, cerebral palsy, spinal cord injury, brain trauma, and stroke.
Originally developed in the 1920s as a potential antiepileptic drug, baclofen was also found to be safe and effective for reducing spasticity. In the early 1980s, the drug was noted to be more effective when delivered intrathecally. Baclofen intrathecal injection was first approved in 1992 as an orphan drug and is now considered the standard of care for patients with severe spasticity of spinal and cerebral origin.
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Gablofen is administered in the same standard concentrations as Lioresal Intrathecal (Novartis): 50 mcg/mL, 500 mcg/ mL, and 2,000 mcg/mL. It is sold with ready-to-use vials and pre-filled syringes offering clear advantages over glass ampules, including a faster refill preparation time and a lower risk of product con tamination.
The company’s research was partly funded by a grant from the Michael J. Fox Foundation.
Source: CNS Therapeutics, www.cns- therapeutics.com, www.gablofen.com