Opioid Dependence:  Developing Depot Buprenorphine Products for Treatment
Opioid Use Disorder Developing Depot Buprenorphine Products for Treatment open cder 2017-1067 2018-1008 Opioid Use Disorder Developing Depot Buprenorphine Products for Treatment open cder
2018-07-06
FDA-2018-D-1334-0005
04:00:00
https://api.regulations.gov/v4/comments/FDA-2018-D-1334-0005
Anonymous
Anonymous
With our rapidly changing society and health care system, opioid addiction has become a major problem all over the United States. The use of depot buprenorphine is one solution to help in decreasing opioid dependence. With the trial being a controlled, blinded study testing the doses seemed to prove to help. The patients that were tested with different characteristics such as new participants to treatment, the already stable patients like if the patient has a relapse, and patients that are not very like to prove effectiveness. Patients that are being seen at least weekly help to keep the studies current and allow for adjusting the dosages to better help to decrease the dependence on opioids. Since they are being checked weekly, it helps to build rapport with the patients making them more willing to come forward with what opioids they may have taken. The endpoints for patients help to better determine the studies effectiveness. With the reduction of cravings, improvement in sleep or mood, or other reported outcomes better helps to demonstrate the benefit of the depot buprenorphine. With the information about cravings, sleep, and mood this could lead to more products like buprenorphine being approved. One study done that was randomized with 428 participants. Forty-eight participants had a reaction at the injection site. With the buprenorphine 17.4% had a good response and 14.4% had a good response with the placebo. (Lofwall  et. el, 2018) If this only helps a few people with opioid dependence it would be worth it. Plus with more studies done it can help even more.Lofwall  et el. (2018). Weekly and monthly subcutaneous buprenorphine depot formations vs daily sublingual buprenorphine with naloxone for treatment of opioid use disorder: a randomized clinical trial. JAMA Inter Med. 1;178(6):764-73. doi: 10.1001/jamainternmed.2018.1052.