IntelGenx Corp., a Canadian drug delivery company focusing on oral drug delivery, has submitted its Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for approval of a generic formulation of buprenorphine and naloxone sublingual film, indicated for maintenance treatment of opioid dependence. The ANDA was filed by IntelGenx' US based co-development and commercialisation partner for this product.
The reference listed drug is Suboxone (buprenorphine and naloxone) Sublingual Film.
"We are very excited with this ANDA filing as we believe that this product represents the most significant milestone in the history of our company to date," commented Dr Horst Zerbe, IntelGenx' president and CEO. "We are very proud of our achievements in completing full development, testing and filing of the product within such a short amount of time following the execution of the development and commercialization agreement with our co-development partner."
According to IMS Health, US retail sales of Suboxone Sublingual Film were approximately $1.5 billion in 2012.
In accordance with confidentiality clauses contained in the co-development and commercialisation agreement, the specifics of the product description and financial terms remain confidential. IntelGenx will receive a share of the profits of commercialization, in addition to upfront and milestone payments.
The FDA approved Suboxone in October of 2002 for use in the treatment of opioid addiction. Suboxone is a registered trademark of and manufactured by Reckitt Benckiser Pharmaceuticals. Suboxone is composed of the two active ingredients: buprenorphine and naloxone.
Naloxone is used to block the effect of opioids. Buprenorphine is a partial opioid agonist that stimulates opioid receptors but does not produce the same effects as an opioid. In other words it does not produce a euphoric "high" effect. The combination of these two actives has been shown to be efficacious in managing the treatment of opioid addiction. Suboxone is most often taken sublingually (dissolved under the tongue). Taken properly it can reduce opioid use, help patients to be successfully managed in an addiction rehabilitation programme, and depress the symptoms of opioid withdrawal. Suboxone is the most commonly prescribed medication that is administered to patients during the maintenance phase of treatment. Unlike methadone, Suboxone has a lower potential for overdose and abuse. This enables Certified Doctors, in certain circumstances, to prescribe take home supplies of Suboxone.