FDA approves Valeant’s Siliq for plaque psoriasis
WASHINGTON — The U.S. Food and Drug Administration approved Valeant Pharmaceuticals’s Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis.
Siliq is administered as an injection. It is intended for patients who are candidates for systemic therapy (treatment using substances that travel through the bloodstream, after being taken by mouth or injected) or phototherapy (ultraviolet light treatment) and have failed to respond, or have stopped responding to other systemic therapies.
"Moderate-to-severe plaque psoriasis can cause significant skin irritation and discomfort for patients, and today’s approval provides patients with another treatment option for their psoriasis," said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. "Patients and their health care providers should discuss the benefits and risks of Siliq before considering treatment."
Psoriasis is a skin condition that causes patches of skin redness and flaking. According to the FDA, Siliq’s safety and efficacy were established in three randomized, placebo-controlled clinical trials with a total of 4,373 adult participants with moderate-to-severe plaque psoriasis who were candidates for systemic therapy or phototherapy. More patients treated with Siliq compared to placebo had skin that was clear or almost clear, as assessed by scoring of the extent, nature and severity of psoriatic changes of the skin.
Mayne Pharma releases migraine generic
GREENVILLE, N.C. — Mayne Pharma launched Butalbital acetaminophen (APAP) tablets, 50mg/300mg in the United States. Butalbital/APAP is indicated for the treatment of tension headache (migraine).
Mayne Pharma will distribute the drug on behalf of its partner, Mikart, which developed the product and also is manufacturing the product.
“We are very pleased to have licensed this product from Mikart, one of our strategic partners,” said Mayne Pharma CEO Scott Richards. “This will be the first generic alternative to BUPAP and will bring patients and payers improved medication affordability.”
Mayne Pharma directly markets more than 50 products and has a growing pipeline of more than 40 generic and branded drug products targeting U.S. markets with IMS sales greater than $6 billion.
The Little Clinic introduces ‘We’ll Hold Your Spot’
NASHVILLE, Tenn. — The Little Clinic, introduced “We’ll Hold Your Spot,” an online tool that allows consumers to reserve a spot in line before they get to a clinic.
The wholly-owned subsidiary of Kroger launched this service at 215 of its clinics located inside select Kroger, Dillons, Fry’s, Jay C and King Soopers in 10 states.
To reserve their spot in line, customers log onto www.TheLittleClinic.com and select their clinic location. They will immediately see what the current wait time is and, if needed, they can click on "We'll Hold Your Spot," provide basic information, and receive a unique registration code and approximate time to come to the clinic.
"'We'll Hold Your Spot' is an extension of our ongoing customer-first approach, a commitment we share with our parent company," said Margaret Lewis, innovation manager of The Little Clinic. "In today's market, consumers want quality care but they want it on their schedule. This initiative is just another example of how The Little Clinic is a leader in being responsive to our valued patients by providing them an easier way to access healthcare so they can continue to live healthy lives."
The Little Clinic locations are staffed with board-certified nurse practitioners and physician assistants authorized to diagnose, treat, and write prescriptions for many common illnesses such as bronchitis, sinus infections, seasonal allergies and the flu. The clinics also provide a wide selection of additional wellness services such as physicals, health screenings, tobacco cessation, and a number of vaccinations. The Little Clinic provides care for the entire family from age 12 months and up (18 months and up in the state of Mississippi and 24 months and up in the state of Kentucky), seven days a week, including evenings. Clinics accept both insured and self-pay patients.
"The premise of our company is to serve the well-being of our customers and 'We'll Hold Your Spot' does just that," said Lewis. "We don't require patients to use this tool and walk-ups are always welcome. For those, however, who want to go ahead and reserve a place in line before heading to the clinic, this is a new customer-friendly, easy-to-use option."