FDA approves Iroko’s NSAID for chronic pain
PHILADELPHIA — Pharmaceutical company Iroko announced today that capsules of its anti-inflammatory drug Zorvolex had been approved by the Food and Drug Administration. This version of the drug is intended to manage pain for those with chronic osteoarthritis. Zorvolex was approved in the United States in October 2013 for the treatment of mild to moderate acute pain in adults.
“Expanding the use of Zorvolex beyond acute pain to osteoarthritis pain, a chronic condition, is a testament to Iroko’s continued commitment to developing a low dose NSAID portfolio to address a broad range of unmet patient needs,” said John Vavricka, Iroko’s president and CEO, said. “This second approval for Zorvolex continues to lay the groundwork for our future portfolio, which utilizes a new approach to pain management.”
In reformulating the drug to manage chronic pain, Iroko followed the FDA’s recommendation that non-steroidal anti-inflammatory drugs contain the minimum effective dose that works for the shortest time. The particles of active ingredient diclofenac are smaller than in normal NSAIDs, but absorption isn’t delayed.
“NSAIDs continue to be an integral part of the management for osteoarthritis, the most common type of arthritis, and their use is likely to increase as the U.S. population continues to age and the incidence of osteoarthritis rises,” said Dr. Roy Altman, a rheumatology professor at the University of California, Los Angeles, said. “The approval of Zorvolex is a welcome and meaningful advance and is the first SoluMatrix NSAID option approved by the FDA for osteoarthritis pain.”
Zorvolex for chronic pain is currently available by prescription.
FDA approves Triumeq for treatment of HIV-1
LONDON — ViiV Healthcare announced that the Food and Drug Administration has approved Triumeq (abacavir 600 mg, dolutegravir 50 mg and lamivudine 300 mg) tablets for the treatment of HIV-1 infection. Triumeq is the company's first dolutegravir-based fixed-dose combination.
"ViiV Healthcare is committed to delivering advances in care and new treatment options to physicians and people living with HIV. We are proud to announce this important milestone, marking the second new treatment to be approved in the US from our pipeline of medicines," Dr. Dominique Limet, CEO ViiV Healthcare, said.
Vigilant to roll out smart toothbrush for kids
SAN FRANCISCO — Smart device and app maker Vigilant is launching its new Bluetooth-enabled Rainbow toothbrush that’s meant to teach children to brush properly. The toothbrush connects to the company’s app, and tracks the brush’s movement in real time.
“At Vigilant, we belive highly innovative products like Rainbow can actually change the way people manage their health,” Laura Loveman, Vigilant’s VP of U.S. operations said. “Our mission is to design and develop devices with smart apps to empower users to make smarter, healthier daily decisions.”
As children brush, the app makes the activity into a game that actually encourages proper brushing techniques. It keeps a record of how the child brushes for parents to check in on.
In addition to Rainbow, Vigilant also makes a smart insulin injection pen that will transmit data on injections and blood glucose levels to the accompanying app, and various other smart devices for the home.
The Rainbow toothbrush retails for $49.99 and is available for preorder on Amazon.com and USVigilant.com, and the app is available for both iOS and Android smartphones and tablets.