FDA tries a new approach with guidance on opioid use disorder medications
Thursday, May 24, 2018
In the United States, the opioid epidemic is recognized as a growing public health crisis that has been identified across all levels of socioeconomic status.
Within the last 16 years, it is reported that more than 183,000 American have died as a result of prescription opioid overdoses.
Members of the medical community and government officials have been attempting to develop strategies to curtail the rise of addictions and deaths related to the crisis. The declaration of the problem as a public health emergency has brought an increasing level of awareness about the impact that opioid addiction can have on a number of Americans.
Recently, a new approach has been adopted by the Food and Drug Administration (FDA) in the form of a guidance document to assist pharmaceutical manufacturers with the development of medications to treat those with an opioid use disorder.
When an individual’s qualify of life and functioning become compromised as a result of the disorder, attempts are made to immediately target and begin the process of treatment. The new report from the FDA seeks to highlight the importance of medication-assisted treatment for opioid use disorder. It also helps to expedite the process for developing medications to target opioid use disorder.
The lack of appropriate access to medication-assisted treatment is a prevailing issue across the nation. However, if data related to trial design, efficacy endpoints, and safety information are already available for new products, this can potentially reduce the time for the approval of the products to help opioid use disorder patients.
FDA Commissioner Scott Gottlieb said of the guidance, "Unfortunately, far too few people who suffer from opioid use disorder are offered an adequate chance for treatment that uses safe and effective medications. The FDA will continue to encourage more widespread innovation and development of new and better treatments for opioid addiction as well as tackle the unfortunate stigma that’s sometimes associated with use of these treatments. More widespread adoption of treatment with safe and effective medications, coupled with relevant social, medical and psychological services, has the highest probability of being the most effective way to help those suffering from opioid addiction transition to lives of sobriety."
Given the growing number of individuals in America who now have this disorder, it is of the utmost importance that effective measures are taken to address an issue that affects the lives of many people across the country.
The goal is to strive to develop improved treatment options, and work towards the promotion and acceptance of drug treatments that are considered to be safe and effective medications for all those that are suffering from an opioid addiction.
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