The opioid crisis has taken its toll on the U.S. with the staggering number of deaths from overdose and the growing need for treatment resources. More than 130 people die from an opioid overdose every day in the country and the number has been continuing to grow. It has been proven that one of the most effective ways to prevent overdose and treat opioid addiction is through replacement medications like methadone and buprenorphine.
Unfortunately a new addiction drug may be blocked from coming on the market for years because of a loophole in federal law. Having different options for medications can be helpful for opioid patients because they may have to try a few until they find one that works best for them. With limited options, it can be more difficult for people in treatment to be able to stick with a recovery program.
Many people in recovery use methadone which they need to take every day and others use Vivitrol which is injected only once a month and can be more convenient. Others use buprenorphine which comes in a dissolvable tablet which they can take twice a day. A new form of buprenorphine called Sublocade that is only injected once a month may now be the only one of its kind available on the market for five years.
Sublocade was given 3 years of exclusive access to U.S. markets because of FDA laws and it may even be granted seven years exclusive access if it is designated an orphan drug. Competitive drugs that have already been deemed safe by the FDA may not be allowed to enter the market because of these laws in spite of the great need for alternative options for patients. Allowing alternative versions of injectable buprenorphine could help save lives if the FDA decides to avoid giving exclusive access to one drug during the crisis.