FDA to Expand Medication-Assisted Treatment for Opioid Addiction

March 5, 2018

On Saturday, February 24, 2018, Health and Human Services (HHS) Secretary, Alex Azar announced that the FDA would be issuing guidance documents regarding expanded access to medication-assisted treatment (MAT) for opioid addiction.

What is Medication-Assisted Treatment?

The recent HHS announcement is part of FDA’s broader effort to encourage new treatments for opioid addiction.  MAT combines pharmacological treatment with substance abuse counseling and other behavioral supports.  Currently, there are three FDA-approved products for the treatment of opioid addiction, including:

  1. Buprenorphine
  2. Methadone
  3. Naltrexone

These drugs, which are used to reduce the cravings and withdrawal symptoms associated with opioid addiction, are intended to assist in the detox process.

Upcoming Guidance Documents

According to an article in the New York Times, the FDA plans to release two new related draft guidance documents in the coming weeks.  The first guidance will focus on improving the effectiveness of existing drugs.  More specifically, the FDA wants to “encourage the development of longer-acting formulations of existing drugs for opioid treatment.” The second guidance will focus on the development of new drugs that “don’t end addiction, but help with aspects of it, such as cravings, or overdoses, with the goal remaining complete abstinence.”  These two guidances will serve as recommendations for drug makers who are interested in developing a product for the treatment of opioid use disorder (OUD).

Lack of Access

In his announcement, Alex Azar noted that only one-third of specialty treatment programs in the United States utilize MAT.  One of the biggest problems with current treatment options is a lack of access for certain patients.  Many of these drugs require consistent administration, making it hard for many people, particularly those living in rural areas, to commit to a regular program.  A recently approved, once-monthly injectable version of buphrenorphine may be a promising indication of the future of OUD treatment.

Are you in the process of developing a drug for the treatment of OUD? Regardless of your product’s indication, we can help you obtain approval of any FDA-regulated product. Contact us today to learn more about our services and how we can help get your product through FDA as quickly and cost-effectively as possible.

Quality & Compliance GMP

May 31, 2017

FDA Warns Drug Manufacturers of Recalls due to BCC Contamination

On Monday, May 22nd, the FDA issued a warning for drug manufacturers regarding the contamination risk posed by Burkholderia cepacia complex (BCC).  According to FDA’s warning, “BCC and other...

Read the Full Article
Quality & Compliance GMP

June 15, 2016

FDA Releases Guidance on Nonclinical Studies for Osteoporosis Drugs

On June 13, FDA released a new pharmacology/toxicology guidance providing guidance on nonclinical studies to support the approval of drugs intended for the treatment of osteoporosis. This guidance...

Read the Full Article
Agency Alerts Regulatory Sciences

March 9, 2016

FDA to Review PhUSE Nonclinical Study Data Reviewer’s Guide Template

As a part of its ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), the FDA has announced its plans to review the proposed Nonclinical Study Data Reviewer’s Guide (SDRG)...

Read the Full Article