US regulators eliminate the bureaucracy of medical devices to curb the opioid crisis

US regulators eliminate the bureaucracy of medical devices to curb the opioid crisis https://www.eresviral.com/wp-content/uploads/2018/11/Los-reguladores-estadounidenses-eliminan-la-burocracia-de-los-dispositivos-médicos-para-frenar-la-crisis-de-los-opioides

US regulators eliminate the bureaucracy of medical devices to curb the opioid crisis







(Reuters) - Laura Perryman hopes that her medical company, Stimwave Technologies Inc, will have to wait several years for her analgesic device to get approval from the US. UU As a treatment for chronic migraines.  











FILE PHOTO: A sign reads "Drug Testing in Session," on the bathroom door of an ambulatory treatment center in Indiana, Pennsylvania, USA. UU., August 9, 2017. REUTERS / Adrees Latif / File Photo





Now he believes it could be done in months, thanks to a new initiative by the United States Food and Drug Administration to use medical device-based treatments, diagnostic tests and mobile medical applications to deal with the opioid crisis in the country. . 

When President Donald Trump declared a public health emergency over the abuse of heavy-use painkillers such as oxycodone and hydrocodone, he ordered all government agencies to take action in response to the deaths of 70,000 Americans last year from opioid overdoses.  

The FDA told Reuters it has received more than 200 submissions from companies seeking a fast approval process for their devices. These range from Stimwave Halo to pain products produced by Abbott Laboratories and other heavyweights in the industry as an alternative to opioids. 

"We are pleased by the strong interest in this innovation challenge and the recognition of the developers on the unique and important role played by medical devices, including digital health technologies such as mobile medical applications, which have the potential to face the crisis of opioids, "FDA commissioner Scott Gottlieb said.      

Perryman's Halo devices, which resemble angel hair paste and are so small that they can be injected into a nerve, took four years to get approval from the US. UU With other names to relieve leg and back pain. 

She hopes that a place in the FDA program will see Halo approved within a year as an alternative to opioids, which are currently used to treat 50 percent of patients who come to emergency rooms with migraines. 

"This is something perfect for something like ours ... because the device is already secure," said Perryman, who founded Stimwave in South Florida seven years ago. 

The FDA has been increasingly reluctant to give the green light to new opioids for the market, but earlier this month it approved a powerful opioid-based painkiller from AcelRx Pharmaceuticals Inc., which imposes strict restrictions on its distribution and use. . In a rare move, Gottlieb made a public statement at that time, explaining the decision. 

The regulator's push for alternatives to opioids has helped attract the interest of venture capital funds and institutional investors this year in firms that promise to develop alternatives, according to interviews with device companies, financial services firms and the Cowen & Runner. Co.  

For example, privately owned Virpax Pharmaceuticals, which manufactures an aerosol that administers a non-opioid analgesic, said it had four or five banks interested in managing its Series A investment round this summer compared to just one in the past. .  

STIMULUS 

Abbott, like its rivals Boston Scientific Corp and Nevro Corp, makes neuromodulation implants that stimulate the nervous system to mask the pain signals before they reach the brain.  

Abbott has sent a ticket to the competition in the hope that it will reduce waiting times, which often last for several months just to get an initial meeting, according to Dr. Allen Burton, medical director of neuromodulation at Abbott.   

"The devices that are part of this (program) will be optimized ... your meeting will go to the top," Burton said. 

While neuromodulation is only a small part of Abbott's large medical device business, the unit is considered a growth engine for the company. Burton estimates that between 10 and 20 percent of the growth that Abbott has seen in his neuromodulation business could be linked to doctors who prescribe their pain devices after surgery or for injuries in patients with opioid aversion.  

Boston Scientific did not apply for the contest, but the company is investing "heavily" in its neuromodulation unit, which had its fastest growth with nearly 23 percent in the last quarter, according to Maulik Nanavaty, senior vice president of the device manufacturer. 

"We continue to make external investments in early technology (neuromodulation)," he told Reuters.  

To be sure, these devices do not look like a silver bullet for opioid addiction. Nirad Jain, a partner at the consulting firm Bain & Co, believes that many of the solutions on the table are only a small part of the problems of a problem that doctors must solve, they simply settle for less powerful opioids or less. 

ADDICTION 

Academic and charitable groups dealing with the social consequences of the crisis say that most of the increase in deaths is due to the misuse of prescription painkillers. That has put in September the responsibility of the regulators to issue new rules to repress the prescriptions of doctors. 

"The goal is for these guidelines to provide evidence-based information about the proper amount of opioid doses to be administered," Gottlieb said in a statement at the time. 

"Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids." 

Although the FDA contest is limited to devices and solutions based on applications for pain and addiction, the current regulatory climate is also conducive for companies to develop alternative opioid pharmaceutical products.     

Drug manufacturers, including Pfizer Inc., Eli Lilly and Co., Regeneron Pharmaceuticals Inc. and Teva Pharmaceutical Industries Inc., have been packing their pipeline with possible solutions to the crisis and there are 120 non-opioid drugs under FDA review. year, 650 percent more since 2013. According to the business intelligence firm Informa.  

(For interactive non-opioid drug applications, click on tmsnrt.rs/2ReUI2H) 

The private company SPR Therapeutics Inc. told Reuters that it entered its "temporary" neuromodulation device in the contest. Similar to Stimwave, your product is implanted in the body, but it can be surgically removed after about two months. Josh Boggs, a senior executive at the company, hopes to get a quicker response from the FDA and shorter review times in the wake of the crisis. 

After years in the business, he believes that the crisis has increased the agency's desire to collaborate with medical technology companies like his.      

"I feel that (FDA) people are well prepared for meetings and are very committed to them, and it feels like an environment conducive to finding a solution," he said. 





Report of Tamara Mathias in Bengaluru; Edited by Patrick Graham and Edward Tobin





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