DDS-06C:
Twice-Daily Tramadol-Acetaminophen Combination

Our Product

We are developing a twice-daily tramadol-acetaminophen combination formulation to provide immediate and sustained relief of acute pain.  The treatment of acute pain accounts for approximately 40% of the US$30 billion global analgesic market.  Effective treatment typically requires medications that have an early onset of action. It has, however, been a significant challenge to achieve both analgesic strength and duration of pain relief, giving rise to the use of drugs in combination, as well as the use of controlled-release forms. Tramadol-acetaminophen combination products were developed to leverage the unique, but complementary, modes of action of each of the active ingredients to provide the analgesic strength of a mild opioid with the rapid pain relief of acetaminophen.

Our unique formulation of tramadol-acetaminophen is designed to improve patient benefit by significantly extending the duration of pain relief beyond that of the currently marketed immediate-release products. Leveraging our Contramid technology’s ability to control the release of two active ingredients simultaneously, we believe that our twice-daily formulation of tramadol-acetaminophen, in addition to providing immediate relief of moderate to moderately severe pain, can also provide sustained relief for a full twelve-hour period, allowing patients to enjoy pain relief all day and all night by taking just one pill in the morning and one pill in the evening.

Market Opportunity

Sales of tramadol-acetaminophen combination products have been experiencing significant growth since their introduction. Over the past five years, global sales of these products have grown at a compound annual rate of 25%, reaching 1.5 billion standard units in 2008. With only immediate-release, four- to six-times daily products currently available to patients, we believe that our sustained-release formulation will provide an excellent option in the treatment of acute pain and capture a significant portion of the market.

Status

Our phase III clinical trial has been completed and we are preparing to submit regulatory applications in Europe, Canada and other key markets in the rest of the world.  We are in discussion with regulatory authorities in the United States regarding a potential submission in that country.

Currently evaluating regulatory path forward for the U.S. and Canada.