New Products for pharmacists

June 15, 2013

New Rx, Generics, and OTC

NEW RX

In May, FDA approved Bayer’s Xofigo (radium Ra 223 dichloride), a treatment for advanced prostate cancer, three months ahead of schedule under its priority review program. Xofigo is indicated for men who have already received medical or surgical therapy to lower testosterone and whose symptomatic late-stage (metastatic) castration-resistant prostate cancer has spread to bones but not to other organs. Clinical trial results showed that men receiving Xofigo lived a median of 14 months compared to a median of 11.2 months for men receiving placebo. The treatment also delayed painful bone metastases, reducing bone pain and offering a better safety profile, with a median 64% delay in the first "skeletal event" for patients. The most common side effects reported were nausea, diarrhea, vomiting, and swelling of the leg, ankle or foot. The most common abnormalities detected during blood testing included low levels of red blood cells (anemia), lymphocytes (lymphocytopenia), white blood cells (leukopenia), platelets (thrombocytopenia) and infection-fighting white blood cells (neutropenia). (www.xofigo-us.com)

Shionogi has announced that Osphena (ospemifene), an estrogen agonist/antagonist with tissue selective effects, is now available by prescription in pharmacies across the United States for the treatment of moderate to severe dyspareunia (painful intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. FDA approved Osphena in February. Dyspareunia is one of the most commonly experienced symptoms of VVA, a chronic and progressive condition affecting approximately 32 million postmenopausal U.S. women, 93% of whom are not being treated with a prescription medication. Approximately 70% of women living with symptoms of VVA go undiagnosed. Osphena is the first approved oral treatment alternative to vaginal or oral estrogens for women with moderate to severe dyspareunia due to menopause. In the endometrium Osphena has estrogen agonistic effects. It carries a boxed warning for endometrial cancer and cardiovascular disorders. Serious risks of estrogen-alone therapy or Osphena can include increased risk of endometrial cancer, stroke, and deep vein thrombosis. Osphena should be prescribed for the shortest duration consistent with treatment goals for the individual woman. (www.Osphena.com)

FDA has approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder; GlaxoSmithKline/Theravance) as a long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations. A combination of fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), the drug carries a boxed warning that LABAs increase the risk of asthma-related death. Breo Ellipta is not approved for the treatment of asthma, as its safety and efficacy for that condition have not been established. The drug should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm) and is not recommended for people younger than 18 years. Serious side effects include increased risk of pneumonia and bone fractures. The most common side effects include inflammation of the nasal passage (nasopharyngitis), upper respiratory tract infection, headache, and oral candidiasis (thrush). (www.gsk.com)

Novartis has FDA approval of Ilaris (canakinumab) to treat patients two years of age and older with active systemic juvenile idiopathic arthritis (SJIA) a rare, disabling autoinflammatory disease that is the most severe subtype of juvenile idiopathic arthritis and has limited treatment options. Ilaris is a selective, fully human, monoclonal antibody that inhibits IL-1 beta, part of the body's immune system defenses. Excessive production of IL-1 beta plays a prominent role in certain inflammatory diseases. Ilaris works by neutralizing IL-1 beta for a sustained period of time, therefore inhibiting inflammation. It is the first interleukin-1 beta (IL-1 beta) inhibitor approved for SJIA and the only treatment approved specifically for SJIA that is given as a once-monthly subcutaneous injection. Clinical trial results showed that after receiving a single subcutaneous dose of Ilaris, 84% of patients showed significant improvement of systemic and arthritic symptoms. Corticosteroids are often used to treat SJIA despite their association with potentially serious adverse effects, including Cushing syndrome, growth suppression and osteoporosis. The approval of Ilaris offers young patients an opportunity to reduce corticosteroid use and limit the effects of such side effects. (www.ilaris.com)

NEW GENERICS

In May, Mylan announced FDA approval of zolmitriptan tablets (generic for Zomig from IPR Pharmaceuticals) to treat acute migraine with or without aura in adults. It is not indicated for the prevention of migraine attacks or cluster headaches.  The product will be manufactured in 2.5-mg and 5-mg strengths. Shipping has begun. (www.mylan.com)

Pfizer subsidiary Greenstone LLC has added oxaprozin caplets 600 mg (generic for Pfizer’s Daypro) to its line of generic pharmaceuticals. Oxaprozin is a nonsteroidal anti-inflammatory drug indicated for relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Adverse reactions may include serious gastrointestinal toxicity such as bleeding, ulceration, and perforation, and kidney toxicity. Individuals sensitive to this material or other materials in its chemical class may develop allergic reactions. Clinical use has resulted in liver effects; symptoms may include jaundice, liver function test abnormalities, and hepatitis. (http://www.greenstonellc.com/product-list.aspx)

In April, Promius Pharma LLC, a specialty company owned by Dr. Reddy’s Laboratories, launched zenatane capsules (an A/B equivalent of Mylan’s Amnesteem), a newly approved isotretinoin option for patients with severe, recalcitrant, nodular acne. The product will be supported by The Promius Promise, a pharmacy service that offers educational support about treatment requirements, reduced out-of-pocket expenses for eligible patients, and 24-hour delivery within the United States. According to a spokesman for the manufacturer, “Based on an FDA review of year 5 of the iPLEDGE program, over 400,000 attempts to fill isotretinoin prescriptions were denied due to failures to meet iPLEDGE requirements. We hope The Promius Promise can help.” (www.zenatane.com / www.promiuspharma.com)

NEW OTC

Designed specifically to improve the appearance of bruising, DerMend Moisturizing Bruise Formula helps to rejuvenate and maintain the skin’s firmness and elasticity that may have been lost from UV damage, genetics, aging, or use of medications such as blood thinners. DerMend’s nonirritating formula helps rejuvenate and restore the skin’s natural barrier, improves the appearance of discolored skin, reduces the look of mottled pigmentation, improves skin texture, maintains collagen and elastin production, and boosts moisture and suppleness. Dermend contains an alpha hydroxy acid (AHA) that may increase sensitivity to the sun and the possibility of sunburn. The product is available online and at select CVS stores nationwide. (www.dermend.com)

Nordic Naturals has launchaed ProEPA Elite, featuring a high dose (1600 mg per serving) of Omega-3 eicosapentaenoic acid (EPA), an essential fatty acid that has anti-inflammatory properties and supports heart health. Pro EPA Elite is an EPA-only formula that contains a dose of fish oil similar to a much-studied ethyl-ester EPA formulation. This dose of EPA has been demonstrated in clinical studies to be beneficial in reducing triglycerides and other cardiovascular risk factors. Pro EPA Elite differs from the study product in that it is formulated in the more bioavailable triglyceride form that is available over the counter. Nordic Naturals offers four products in varying amounts of omega-3 EPA: ProEPA, ProEPA Xtra, ProEPA Elite, and ProEPA with Concentrated GLA. (www.nordicnaturals.com)