Showing posts with label food and drug administration. Show all posts
Showing posts with label food and drug administration. Show all posts

Saturday, June 20, 2015

Biotech firm buys UK professor's anti-overdose nasal spray

Pharmacy Professor Daniel Wermeling at the University of Kentucky invented a nasal spray to fight heroin overdoses, and a biotech firm has bought the product, which may be on the market within six months, pending approval by the U.S. Food and Drug Administration. The device "contains a single dose of a mist form of naloxone and delivers the drug in a way similar to how Flonase is used to treat allergies," Mary Meehan reports for the Lexington Herald-Leader.

The product is on a fast track for approval because of the rising rates of heroin overdoses across the country, said UK Provost Tim Tracy, former dean of UK's pharmacy school. Wermeling doesn't know exactly when his product will be on the market, but he said the FDA approved another fast-track, anti-overdose therapy after only 14 weeks. The fast-track program speeds development of drugs to treat serious or life-threatening conditions. "Last year, 233 people [in Kentucky] died with heroin in their systems, according to the state medical examiner's office," Meehan notes.

Wermeling has been developing the project at UK since 2009 with the help of more than $5 million in federal and state tax dollars. Tracy said Indivior PLC, the spinoff pharmaceutical company that bought the nasal spray, will be able to manufacture, market and distribute the product. Right now, emergency responders and hospitals must draw naloxone, branded as Narcan, in a syringe to provide the correct dose.

Wednesday, June 10, 2015

Partial knee replacement using a robotic arm used in Ky. for first time; offers hope of longer lasting knees that feel more natural

A partial knee replacement surgery that utilizes a robotic arm was performed for the first time in Kentucky in May, Mark Hansel reports for the Northern Kentucky Tribune.
RIO, Robotic Arm System
(Photo from NKYTribune)

Dr. Matthew Hummel of Commonwealth Orthopaedic Physicians, which serves the greater Cincinnati area, performed the Stryker MAKOplasty partial knee resurfacing procedure at St. Elizabeth Edgewood May 19.

Hummel said "benefits of the minimally invasive procedure are expected to include a more natural feeling post-surgery and improved recovery time," Hansel writes.

“Stryker MAKOplasty allows us to treat patients with knee osteoarthritis at earlier stages and with greater precision,” Hummel said. “Because it is less invasive and preserves more of the patient’s natural knee, the goal is for patients to have relief from their pain, gain back their knee motion, and return to their daily activities.”

Osteoarthritis is the most common form of arthritis and a leading cause of disability worldwide, according to the American Academy of Orthopaedic Surgeons.

Hummel said the procedure has been "around for several years," and that he has been tracking its progress, including recent results and upgrades in technology, before using it on his patients.

Hansel explains that the procedure is performed using RIO, a highly advanced, surgeon-controlled robotic arm system. The system correlates a pre-surgical plan that was created by using a CT scan of the patient's knee taken before the surgery with a three-dimensional, virtual view of the patient's bone surface during the procedure.

Hummel told Hansel that some patients are "apprehensive about having a robot perform the procedure," but assures them that "I am actually operating and doing all the work, but it is helping me apply the best laser lines and guiding techniques."

In addition to a more rapid recovery, the procedure is expected to result in reduced pain, a smaller scar, minimal hospitalization, less implant wear and loosening, and better motion that feels more natural, Hansel reports.

“If my implants completely match my plan CT scan, I’m hopeful that with today’s technology, we can have knees that last 25 and 30 years,” Hummel said

Hummel has since performed the procedure on at least one other patients at St. Elizabeth Edgewood. It is anticipated that this procedure will be expanded to total hip and total knee replacements, but these procedures have not yet gained the U.S. Food and Drug Administration's approval.