New Products for Pharmacists 03-10-2016

March 10, 2016

New drugs, formulations, generics, and devices.

RX CARE

New drug

FDA has approved UCB’s brivaracetam (Briviact) as adjunctive therapy for partial-onset seizures in epilepsy patients age 16 years of age and older. A new molecular entity, brivaracetam is an analogue of the already available antiepileptic drug levetiracetam. As with all epilepsy medications, the most serious risks include suicidal thoughts and attempts, agitation, depression, aggression, and panic attacks. Briviact will be dispensed with a Medication Guide. (www.ucb.com)

New formulations

Spiriva RespimatBoerhringer Ingelheim has announced that its inhaled tiotropium bromide (Spiriva Respimat), the first new class of inhaled asthma therapy approved in over 10 years, is now available by prescription for asthma maintenance in patients 12 years and older. A steroid-free long-acting muscarinic antagonist, the bronchodilator is delivered in a once-daily dose of two puffs of 1.25 µg each. A savings card for eligible patients is available at www.SpirivaSavings.com. (www.spiriva.com(Product image courtesy of Boehringer Ingelheim)

VivlodexIroko Pharmaceuticals has announced the U.S. availability of its meloxicam 5- and 10-mg capsules (Vivlodex). FDA approved the once-daily low-dose NSAID formulation in October to treat osteoarthritis pain. Its submicron meloxicam particles are approximately 10 times smaller than their original size, providing an increased surface area that leads to faster dissolution. A boxed warning cites increased risk of serious cardiovascular and gastrointestinal events. (www.vivlodex.com(Product image courtesy of Iroko Pharmaceuticals)

FDA has approved Pfizer’s tofacitinib citrate 11-mg extended-release tablets (Xeljanz XR) to treat moderate-to-severe rheumatoid arthritis (RA) in patients who have experienced an inadequate response or demonstrated intolerance to methotrexate. Xeljanz XR is the first and only once-daily oral RA treatment in its class, known as Janus kinase (JAK) inhibitors. First approved in 2012, Xeljanz carries a boxed warning for serious infections and malignancies, and a Medication Guide. (www.xeljanz.com)

Cipher has announced U.S. availability of the foam formulation of its topical, prescription-only low molecular weight hyaluronic acid (Bionect Foam), previously available as a cream and gel. A nonsteroidal product used to treat inflammation, discomfort, and redness associated with skin irritation, the foam is said by the manufaturer to be especially well-suited for safely dressing and managing hard-to-reach dermal ulcers, wounds, postoperative incisions, and first- and second-degree burns. (www.bionect.com)

FDA has approved Avanir’s low-dose sumatriptan powder with intranasal delivery (Onzetra Xsail), formulated to treat acute migraine with or without aura in adults. A breath-powered device deposits 22 mg of sumatriptan deep in the nose for targeted delivery that limits the likelihood that the medication will go down the back of throat. Sumatriptan is already available as a tablet and injection. (www.onzetra.com)

See also: New Products for Pharmacists 02-10-201

New generics

FDA has approved mixed salts of a single-entity amphetamine product, Impax’s generic version of Shire’s Adderall XR, indicated to treat attention deficit hyperactivity disorder. The product will be available in 5-, 10-, 15-, 20-, 25- and 30-mg dosage strengths. A CII stimulant, the product is accompanied by a Medication Guide and a boxed warning that notes high potential for abuse, as well as risk of sudden death and serious cardiovascular adverse reactions resulting from prolonged administration that leads to dependence and misuse. (www.impaxlabs.com)

Tolterodine tartrate ERGreenstone has launched tolterodine tartrate extended release capsules, indicated to treat symptoms of overactive bladder such as incontinence or frequent urination. Available in in 2-mg

Nadololand 4-mg dosage strengths, this product is the authorized generic version of Pfizer’s Detrol LA. (www.greenstonellc.com(Product image courtesy of Greenstone llc)

Camber Pharmaceuticals has launched nadolol tablets in 20, 40, and 80 mg. The generic version of Pfizer’s Corgard, this product is indicated to treat high blood pressure and chest pain. (www.camberpharma.com(Product image courtesy of Camber Pharmaceuticals)

Imatinib mesylate

Sun Pharma has announced the U.S. launch of imatinib mesylate  in 100 and 400 mg, a therapeutically equivalent version of Novartis’ Gleevec, indicated to treat adults with chronic myeloid leukemia with Philadelphia chromosomes, as well as several other cancers. A savings program is dsesigned to reduce some patients’ co-pays to $10, and a patient assistance program may enable eligible patients to receive the drug at no cost. (www.imatinibrx.com(Product image courtesy of Sun Pharma)

     

New devices

The app invasion of the human body continues, with the Oral B Genius, a tricked-out toothbrush that uses location tracking technology to record how poorly you are brushing and where. It rates you on how long you brush, how much pressure you use, and the dental zones you neglect, which it does using facial identification technology keyed to your smartphone, which you stick on the bathroom mirror and stare into as you brush. There’s more - much more - going on at Oral B. So until the
Genius launches this fall, you can browse the Oral B website and stare the future in the face. (www.oralb.com)

It’s not just e-cigs anymore. For evidence of vape creep, look no further than the B12 Vaporizer from VitaminVape. Vitamin B12, otherwise known as cyanocobalamin, supports the adrenals, the nervous system, and more. According to the manufacturer, “Studies have shown the body only needs a small amount of vitamin B12 every day, which equals to 10-20 puffs daily with VitaminVape.” Each Vaporizer is said to contain 14 energy shots, equal to “hundreds of puffs.” Suggested price, $10 each. (www.vitaminvape.co)

Have you heard about the Sneeve? Made of a soft stretchy material, it goes over a kid’s sleeve for use as a cough-and-sneeze catcher. The Sneeve is antimicrobial and one will last most of the day. A week’s worth costs $10. Available now online, it’s coming to U.S. retailers early next year. (www.thesneeve.com)

See also: New Products for Pharmacists 01-10-2016

New technology tool

Pharmacies doing business with Smith Drug Company have learned that it is now using P4 Technologies’ cloud-based forecasting and replenishment software platform, which uses sophisticated algorithms to determine how much, and what type, of inventory should be maintained so that products are readily available for pharmacies to order and provide to their
patients. (www.smithdrug.com)