INTERMEDICS" INFUSAID PUMP GETS FDA APPROVAL FOR USE WITH AMIKIN (amikacin), Bristol Labs' antiobiotic for the treatment of osteomyelitis, Intermedics announced Oct. 7. As a result of the FDA action, the company said, the implantable pump manufactured by Intermedics' Infusaid subsidiary can now be used to deliver the antiobiotic amikacin "directly to the site" of an osteomyelitis infection. "This opens the potential for a new era of antiobiotic therapy in which these serious, chronic infections can be cured more effectively and far less expensively," Intermedics Chairman Russell Chambers said. Osteomyelitis affects 1.1 mil. Americans each year, according to Intermedics, and requires more than 20,000 hospitalizations annually. "It often develops after a fracture or other traume exposes the bone to bacterial infection," the firm noted. "Severe cases ae usually incurable with conventional therapy and can frequently lead to amputation." Aminoglycoside antiobiotics like amikacin, Intermedics stated, "are effective against most of the micro-organisms that cause osteomyelitis but, when administered intravenously at the dosage level needed to be effective against the infection, they can cause kidney damage and loss of hearing." A clinical trial conducted at St. Louis University Medical Center was designed to avoid these systemic side effects by using an Infusaid pump implanted in the patient's abdomen to deliver the antibiotics by internal catheter directly to the infection site. Intermedics reported: "Eleven of 14 patients treated in the tests -- all of whom had failed earlier treatment -- have demonstrated no further infection or wound drainage, and suffered no significant side effects, during an average follow-up period of 15 months after therapy." Clayton Perry, MD, who conducted the trial at St. Louis, commented: "In addition to delivering high concentrations of drug to the infected site with a high degree of patient safety, the Intermedics Infusaid pump also allowed patients to be discharged from the hospital after an average of just over three weeks -- almost six weeks early -- because they could receive amikacin therapy at home. Since antibiotics like amikacin must ordinarly be monitored closely by nursing staff when delivered systemically, we can also assume that the costs of implanting and removing the pump are more than offset by this dramatic reduction in hospital stay." In an effort to reduce dependency on its pacer business, Intermedics has singled out infusion pump products as "good opportunities for growth" in 1985 and beyond. The company pointed out in its Oct. 7 release that the Infusaid device "is the only implantable drug delivery system which has received premarket approval from the FDA for use with the drugs FUDR, 5-FU, morphine and heparin, in addition to amikacin." The implantable pump is also under clinical investigation with the drug bethanechol chloride, "which -- when delivered directly into the brain -- may halt or slow the progress of Alzheimer's disease," Intermedics noted. The study is underway at the Hitchcock Medical Center at Dartmouth College.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.
As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.
