[{"innerBlocks":[],"name":"core\/freeform","postId":1453,"blockType":{"name":"core\/freeform","keywords":[],"attributes":{"content":{"type":"string","source":"raw"},"lock":{"type":"object"}},"providesContext":[],"usesContext":[],"selectors":[],"supports":{"className":false,"customClassName":false,"reusable":false},"styles":[],"variations":[],"apiVersion":3,"title":"Classic","description":"Use the classic WordPress editor.","category":"text"},"originalContent":"The Food and Drug Administration has granted clearance to a mobile medical app designed to help keep patients with opioid use disorder in recovery programs.

The app from Pear Therapeutics, called reSET-O, is meant to be used in outpatient treatment programs, serving as a training, monitoring and reminder tool for providers and patients.

\u201cOften on the road to recovery, patients find their commitment to staying in treatment may wane,\u201d said FDA Commissioner Scott Gottlieb, MD, in a written statement. \u201cProviding Americans suffering from opioid use disorder with more options and proper support to address treatment challenges is key to helping them succeed. We know medication-assisted treatment works and we support novel ways to keep individuals more engaged in their treatment programs and to provide clinicians with new ways to intervene to help them remain in treatment.\u201d

Also See:<\/b> FDA launches app competition to combat opioid overdoses<\/a>

The app, which is downloaded to a patient\u2019s mobile device after it\u2019s prescribed by a physician, is a prescription cognitive behavioral therapy intended to be used in addition to outpatient treatment under the care of a healthcare provider, along with treatment that includes buprenorphine and contingency management\u2014a behavior modification intervention that creates a connection between new, targeted behavior and the opportunity to obtain a desired reward.

According to the FDA, it reviewed data from a multi-site, unblinded, controlled 12-week clinical trial of 170 patients who received supervised buprenorphine treatment combined with a behavior therapy program\u2014either with or without the addition of a desktop-based version of reSET-O.

\u201cThe use of reSET-O was not shown to decrease illicit drug use any more than patients who received buprenorphine treatment and contingency management alone,\u201d states the regulatory agency. \u201cHowever, the data showed a statistically significant increase in retention in a treatment program for 12 weeks for the patients who used the desktop computer version of the reSET-O program, compared to those who did not.\u201d

Specifically, the FDA reported that patients in the clinical trial who used the desktop computer version of reSET-O had an overall retention rate\u2014through the end of 12 weeks of treatment\u2014of 82.4 percent, compared with 68.4 percent overall retention rate for patients who did not.

\u201cThe reSET-O app has not been shown to decrease illicit drug use or improve abstinence in patients with (opioid use disorder),\u201d emphasizes the agency. \u201cThe app is not intended to be used as a stand-alone therapy, as a substitute for medication or for patients whose primary language is not English.\u201d

\u201cNearly 50,000 drug overdose deaths involving opioids, including prescription pain medications and heroin, took place in the U.S. in 2017,\u201d says Corey McCann, MD, president and CEO of Pear Therapeutics. \u201cThere is an urgent need for new and innovative therapeutics to address this public health epidemic. This groundbreaking decision by the FDA ushers in a new standard for treating patients with opioid use disorder and it signals a new path for therapeutic software to be used in conjunction with pharmacotherapy to improve efficacy.\u201d","saveContent":"The Food and Drug Administration has granted clearance to a mobile medical app designed to help keep patients with opioid use disorder in recovery programs.

The app from Pear Therapeutics, called reSET-O, is meant to be used in outpatient treatment programs, serving as a training, monitoring and reminder tool for providers and patients.

\u201cOften on the road to recovery, patients find their commitment to staying in treatment may wane,\u201d said FDA Commissioner Scott Gottlieb, MD, in a written statement. \u201cProviding Americans suffering from opioid use disorder with more options and proper support to address treatment challenges is key to helping them succeed. We know medication-assisted treatment works and we support novel ways to keep individuals more engaged in their treatment programs and to provide clinicians with new ways to intervene to help them remain in treatment.\u201d

Also See:<\/b> FDA launches app competition to combat opioid overdoses<\/a>

The app, which is downloaded to a patient\u2019s mobile device after it\u2019s prescribed by a physician, is a prescription cognitive behavioral therapy intended to be used in addition to outpatient treatment under the care of a healthcare provider, along with treatment that includes buprenorphine and contingency management\u2014a behavior modification intervention that creates a connection between new, targeted behavior and the opportunity to obtain a desired reward.

According to the FDA, it reviewed data from a multi-site, unblinded, controlled 12-week clinical trial of 170 patients who received supervised buprenorphine treatment combined with a behavior therapy program\u2014either with or without the addition of a desktop-based version of reSET-O.

\u201cThe use of reSET-O was not shown to decrease illicit drug use any more than patients who received buprenorphine treatment and contingency management alone,\u201d states the regulatory agency. \u201cHowever, the data showed a statistically significant increase in retention in a treatment program for 12 weeks for the patients who used the desktop computer version of the reSET-O program, compared to those who did not.\u201d

Specifically, the FDA reported that patients in the clinical trial who used the desktop computer version of reSET-O had an overall retention rate\u2014through the end of 12 weeks of treatment\u2014of 82.4 percent, compared with 68.4 percent overall retention rate for patients who did not.

\u201cThe reSET-O app has not been shown to decrease illicit drug use or improve abstinence in patients with (opioid use disorder),\u201d emphasizes the agency. \u201cThe app is not intended to be used as a stand-alone therapy, as a substitute for medication or for patients whose primary language is not English.\u201d

\u201cNearly 50,000 drug overdose deaths involving opioids, including prescription pain medications and heroin, took place in the U.S. in 2017,\u201d says Corey McCann, MD, president and CEO of Pear Therapeutics. \u201cThere is an urgent need for new and innovative therapeutics to address this public health epidemic. This groundbreaking decision by the FDA ushers in a new standard for treating patients with opioid use disorder and it signals a new path for therapeutic software to be used in conjunction with pharmacotherapy to improve efficacy.\u201d","order":0,"get_parent":{},"attributes":[],"attributesType":{"content":{"type":"string","source":"raw"},"lock":{"type":"object"}},"dynamicContent":""}]

FDA approves opioid use disorder app for outpatient treatment

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