New Products

New Rx

GlaxoSmithKline has announced FDA approval of umeclidinium and vilanterol inhalation powder (Anoro Ellipta) as the first fixed-dose combination of a long-acting muscarinic antagonist and a long-acting beta agonist (LAMA/LABA) on the market. The once-daily dry-powder inhaler is indicated for long-term maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD). COPD, a serious lung disease that makes breathing difficult and worsens over time, is the third leading cause of death in the United States. Symptoms can include chest tightness, chronic cough and excessive phlegm. Umeclidinium is an inhaled anticholinergic that affects the muscles around the large airways and stops the muscles from tightening. Vilanterol is a long-acting beta2-adrenergic agonist (LABA) that improves breathing by relaxing the muscles of the airways to allow more air to flow into and out of the lungs. The boxed warning states that LABAs increase the risk of asthma-related death. The product is not approved for the treatment of asthma and should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm). A patient medication guide includes instructions for use and information about the potential risks of taking the drug. (http://bit.ly/anoroellipta)

FDA has approved Merck’s Noxafil (posaconazole) 100 mg delayed-release tablets. Merck also markets Noxafil (40 mg/mL) oral suspension, which is dosed three times daily. Noxafil delayed-release tablets and oral suspension are indicated for the prophylaxis of invasive aspergillus and candida infections in severely immunocompromised patients, 13 years of age and older, who have hematologic malignancies or hematopoietic stem cell transplant recipients and are at high risk of developing these life-threatening fungal infections. The most frequently reported adverse reactions in prophylaxis studies with Noxafil oral suspension were fever, diarrhea and nausea. Noxafil delayed-release tablets and oral suspension are not to be used interchangeably due to the differences in the dosing of each formulation. Noxafil delayed-release tablets should be swallowed whole, and not be divided, crushed or chewed. Dosing regimen and a long list of contraindications is included with prescribing information at the product website. (www.noxafil.com). 

Gilead announced that FDA has approved sofosbuvir (Sovaldi) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the first drug to have demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV. Sofosbuvir is to be used as a component of a combination antiviral treatment regimen for chronic HCV infection. Depending on the type of HCV infection a patient has, the treatment regimen could include Sofosbuvir and ribavirin or Sofosbuvir, ribavirin and peginterferon-alfa. Results from six clinical trials showed that a treatment regimen containing Sofosbuvir was effective in treating multiple types of the hepatitis C virus. Sofosbuvir also showed efficacy in patients who could not tolerate or take an interferon-based treatment regimen and in patients with liver cancer awaiting liver transplantation, addressing unmet medical needs in these populations. The most common side effects reported by study participants treated with sofosbuvir and ribavirin were fatigue and headache. In participants treated with sofosbuvir, ribavirin, and peginterferon-alfa, the most common side effects reported were fatigue, headache, nausea, insomnia and anemia. Gilead has launched Support Path (www.MySupportPath.com; 855-769-7284) to provide assistance to patients who are uninsured, or underinsured, or who need financial assistance to pay for the medication, for which a 12-week course of treatment is currently priced at $84,000. (www.gilead.com)

New generic

Greenstone LLC, a Pfizer subsidiary, has added voriconazole for oral suspension in the dosage strength of 40 mg/mL bottle to its generic pharmaceutical product line. Voriconazole is the authorized generic version of Pfizer’s Vfend for the treatment of deadly fungal infections. Voriconazole is indicated for primary treatment of acute invasive aspergillosis and salvage therapy for rare but serious fungal infections caused by the pathogens Scedosporium apiospermum and Fusarium spp. As more patients undergo bone marrow and organ transplants as well as aggressive chemotherapy for cancer, the number of patients vulnerable to serious fungal infections increases. Fungal infections in immunosuppressed patients are associated with high morbidity and mortality and require prompt and effective treatment. (www.greenstonellc.com/product-list.aspx)

New indication

Auxilium Pharmaceuticals has announced FDA approval of Xiaflex (collagenase clostridium histolyticum) injection, the first approved nonsurgical treatment option for men with bothersome curvature of the penis, a condition known as Peyronie’s disease, caused by a plaque (lump) in the penis that results in a curvature deformity of at least 30 degrees upon erection. 
Peyronie’s disease is caused by scar tissue that develops under the skin of the penis and causes an abnormal bend during erection. It can also cause problems such as bothersome symptoms during intercourse. Xiaflex is a biologic drug first approved in 2010 for the treatment of Dupuytren’s contracture, a progressive hand disease that can affect a person’s ability to straighten and properly use their fingers. Xiaflex is available only through a restricted REMS program because of the risks of serious adverse reactions. Injections should be administered by a healthcare professional experienced in the treatment of male urological diseases. To be REMS-certified, healthcare professionals must enroll in and complete training in the administration of Xiaflex treatment for Peyronie’s disease. Healthcare facilities must also be certified under the REMS. (www.xiaflex.com)

New OTC

EuroPharma Inc.’s Terry Naturally product line has launched Every Body’s Multiple, a multivitamin that provides vitamin B6, B12, and folic acid in their active, most bio-accessible forms - P-5-P, methylcobalamin, and L-methylfolate - requiring no conversion to support energy levels, cardiovascular health, nerve function, carbohydrate metabolism, and amino acid production. According to a company statement, this formula provides the levels of B-vitamins needed by all persons, including women who are pregnant or nursing. To address the mineral deficits and lack of absorption that are typical of other supplements, says the manufacturer, this multiple binds minerals to amino acids through a chelation process that creates an organic molecule the body can easily absorb and use, and provides a full range of other essential nutrients, including vitamin D3 and full spectrum vitamin E from a d-alpha and mixed (alpha, beta, gamma) tocopherol complex. (www.EuroPharmaUSA.com)

Newly launched Good to Go from WELax LLC is the only product on the market that is specifically designed to prevent travelers’ constipation, as opposed to OTC laxatives that recommend starting treatment after constipation begins. Traveler’s constipation is specifically attributed to changes in diet, including dehydration; changes in schedule, including long periods of sitting; shifting mealtimes; irregular or limited access to bathroom facilities; stress; even a psychological preference for one’s own bathroom. Formulated as a four-day preventative regimen, Good To Go contains several different types of natural laxatives - psyllium husk powder, chia seed powder, prune extract, apricot extract, aloe vera latex powder, and senna leaf powder -  which, the company says, offer far greater promise of successful elimination than would OTC laxatives that generally rely only on one key ingredient. This product is formulated with low dosages of the natural ingredients, minimizing the risk of diarrhea, another possible side effect of standard laxatives. (http://www.begoodtogo.com)