New Products for Pharmacists

March 10, 2014

New Rx, indications, generics, and OTC

NEW Rx

FDA has approved droxidopa capsules (Northera; Chelsea Therapeutics) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic, and often debilitating condition in which blood pressure drops upon standing. It is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure. Symptoms of NOH include dizziness, lightheadedness, blurred vision, fatigue, and fainting upon rising. At present, few treatment options exist. FDA has given droxidopa an accelerated approval based on clinical data showing that the drug provides short-term relief of dizziness and suggesting that relief of dizziness during chronic treatment is likely. The company will conduct post-approval clinical trials to verify the drug’s clinical benefit over the long term. Droxidopa has a boxed warning about the risk of supine hypertension, which can cause stroke. The most common adverse events reported in clinical trials were headache, dizziness, nausea, hypertension, and fatigue. The product will be available in the second half of 2014. (http://chelseatherapeutics.com)

BioMarin Pharmaceutical has announced FDA approval of elosulfase alfa (Vimizim), the first FDA-approved treatment for mucopolysaccharidosis Type IVA (Morquio A syndrome), a rare congenital enzyme disorder. Morquio A syndrome is an autosomal recessive lysosomal storage disease caused by a deficiency in N-acetylgalactosamine-6-sulfate sulfatase (GALNS). Elosulfase alfa is intended to replace the missing GALNS enzyme involved in an important metabolic pathway. Absence of this enzyme leads to problems with bone development, growth and mobility. There are approximately 800 patients with Morquio A syndrome in the United States. Elosulfase alfa became the first drug to receive priority review for a rare pediatric disease. Before its approval, there were no approved drug treatment options for Morquio A syndrome. The safety and effectiveness of this product have not been established in pediatric patients less than 5 years of age. It will carry a boxed warning highlighting risk of anaphylaxis. (http://www.bmrn.com)

In February, Anika Therapeutics announced FDA approval of sodium hyaluronate solution (Monovisc), a sterile, nonpyrogenic, single-injection treatment for osteoarthritis of the knee. Anika develops and sells therapeutic products intended to repair and heal bone, cartilage and soft tissues. Because currently there is no cure, osteoarthritis treatment focuses on relieving symptoms and improving function. In the United States, DePuy Synthes, a Johnson & Johnson subsididary, will market the product. It is already sold internationally, including in Canada and the U.K. It will be introduced commercially at the annual meeting of the American Academy of Orthopedic Surgeons taking place in New Orleans March 11-15. (www.monovisc.com)

In February, Jazz Pharmaceuticals announced commercial availability of the first and only oral suspension clozapine USP (Versacloz). The product is used to treat patients with severe, treatment-resistant schizophrenia and to reduce risk of recurrent suicidal behavior in schizophrenic patients. Clozapine should be used only in patients who have failed to respond adequately to standard antipsychotic treatment, as the product carries significant risk of agranulocytosis and seizure, noted in the product’s black-box warning, which also lists orthostatic hypotension, bradycardia, syncope, seizure, myocarditis, cardiomyopathy, and increased mortality in elderly patients with dementia-related psychosis. According to the company, the new formulation helps eliminate the mixing and matching of pill dosage strengths. In institutional settings, it may help with confirmation of administration, and it may reduce the possibility that patients will hide or share the medication. (http://www.jazzpharma.com)

FDA has approved tasimelteon (Hetlioz; Vanda Pharmaceuticals), a melatonin receptor agonist, to treat non-24-hour sleep-wake disorder (“non-24”) in totally blind individuals. A chronic disorder of circadian rhythms in the blind, non-24 causes problems with the timing of sleep. Tasimelteon is the first treatment for this disorder to win FDA approval. People with non-24 may have trouble falling or staying asleep, and may wake up groggy or feeling as if they need more rest. Patients may find that they need to sleep during the day and to be awake at night. According to FDA, there may be as many as 100,000 individuals in the United States with this condition, who can’t perceive enough light to establish a normal night sleep schedule. Non-24 can occur at any age. Tasimelteon can impair activities that require complete mental alertness. It should be taken at the same time every night before bedtime and activities should be limited after taking the drug. Tasimelteon received both priority review and orphan-drug status, as this condition is so rare and no other treatments exist. (www.hetlioz.com)

 

 

NEW FORMULATION

Teva announced in January that FDA had approved its supplemental new drug application for glatiramer acetate injection 40mg/mL (Copaxone), to be dosed at a less frequent three times a week in patients with relapsing forms of multiple sclerosis. In addition to the newly approved dose, the daily subcutaneous injection at 20 mg/mL, which has been available since 1996, will remain available. The new product began shipping immediately. Patients making the transition to the new formulation can obtain assistance through Teva’s Shared Solutions patient support center, which they can contact through their doctors or by calling 800-887-8100. The support center provides 24/7 nurse support, financial and benefits investigation, and location of pharmacy distribution options to support access to the product. It also provides free injection training and ongoing compliance and adherence support services. (www.copaxone.com)

NEW INDICATION

In February, Pharmacyclics and Janssen Biotech announced that FDA had approved an expanded use of the oral agent ibrutinib (Imbruvica) to treat chronic lymphocytic leukemia (CLL) in patients who have received at least one previous therapy. CLL is a rare blood and bone marrow disease that usually worsens over time, causing a gradual increase in white blood cells called B lymphocytes. According to figures from the National Cancer Institute, in 2013 15,680 new U.S. cases were diagnosed and 4,580 patients died. Ibrutinib works by blocking the enzyme that allows cancer cells to grow and divide. It was first approved in November 2013, when FDA gave it accelerated approval to treat patients with mantle cell lymphoma, a rare and aggressive type of blood cancer, if those patients had received at least one prior therapy. Ibrutinib for CLL received priority review because the drug showed potential to improve safety or effectiveness in the treatment of a serious condition. It received orphan-product designation because it targets a rare disease. Ibrutinib is available through five authorized specialty pharmacies: Diplomat, Avella, Biologics, Diplomat, Onco 360, and Total Life Care. (www.imbruvica.com)

 

NEW GENERICS

Sun Pharmaceutical Industries has received final FDA approval of its temozolomide capsules (generic version of Merck Sharp & Dohme's Temodar) in 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg form. Temozolomide capsules are used concomitantly with radiotherapy to treat patients with newly diagnosed glioblastoma multiforme and for adult patients with refractory anaplastic astrocytomas who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. It also serves as a maintenance treatment, the company said. (http://www.sunpharma.com)

In February, Teva launched its moxifloxacin hydrochloride tablets, an AB-rated bioequivalent to Bayer Healthcare’s Avelox tablets, used to treat bacterial infections, including acute sinusitis, acute exacerbations of chronic bronchitis, community acquired pneumonia, skin and skin structure infections, and complicated intra-abdominal infections. (www.tevagenerics.com)

FDA recently approved Hi-Tech Pharmacal's once-daily bromfenac ophthalmic solution, 0.09%, generic for ISTA Pharmaceuticals' Bromday ophthalmic solution, 0.09%. The solution is used to treat postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. The product has launched. (http://www.hitechpharm.com)

Perrigo has received final approval of its repaglinide tablets in 1-mg and 2-mg strengths, generic for Novo Nordisk’s Prandin tablets, used to improve glycemic control in adults with Type 2 diabetes. The company has begun shipping the drug. Perrigo launched the 0.5-mg strength in 2013. (www.perrigo.com)

Perrigo has also launched its fluocinonide cream 0.1%, the generic equivalent to Medicis’ Vanos Cream 0.1%, a corticosteroid indicated to relieve the inflammatory and itchy symptoms of corticosteroid responsive dermatoses in patients 12 years of age or older. Because Perrigo was the first company to submit an ANDA containing a paragraph IV certification, the company said, it was awarded 180-days of generic drug exclusivity. (www.perrigo.com)

FDA has approved telmisartan immediate-release tablets, 20mg, 40mg and 80mg, Actavis’ generic equivalent to Boehringer Ingelheim's Micardis. Micardis is an angiotensin II receptor blocker indicated to treat hypertension, lower blood pressure, and reduce cardiovascular risk in patients unable to take ACE inhibitors. The company received 180 days of generic market exclusivity as a 'first applicant' to submit a substantially complete ANDA. (http://www.actavis.com)

 

 

NEW OTC

Chattem has announced that Nasacort Allergy 24-hour Nasal Spray is now available without a prescription in the United States. According to the company, it is the first and only treatment in its class approved for OTC use that provides 24-hour relief of “the full range of nasal allergy symptoms, including nasal congestion” in adults and children two years of age and older. Nasacort works differently from other over-the-counter treatments by stopping more of the chemical responses that cause those symptoms, the company said. More than 60 million Americans suffer from seasonal and year-round hay fever and other upper respiratory allergies. (www.nasacort.com)

Nordic Naturals has announced a new product, children’s Vitamin C Gummies, providing 250 mg of vitamin C. The product is pectin-based and 100% vegetarian, and free of gelatin, artificial colors, artificial flavors, preservatives, and allergens, including gluten, milk, eggs, tree nuts, peanuts, and soy. Vitamin C is an essential nutrient children need for growth and development. In addition to supporting many of the body’s physiological functions, vitamin C supports a healthy immune system and provides antioxidant protection. (www.nordicnaturals.com)

Dr. Susan Lin’s MD Hair is a line of products made with plant stem cell technology and designed to help women combat female hair loss exacerbated by aging, stress, and hormonal issues. According to the company, the products help stop hair loss and help women have hair that is fuller, thicker, and younger-looking. Products include Nutri Hair, a daily supplement formulated with antioxidants and lignans; Scalp Essentials serum for itchiness, oiliness, flakiness, and thinning hair; and Follicle Energizer serum, which encourages healthy hair growth. (http://mdlashfactor.com)