Rapinylâ„¢
Treatment of acute pain in cancer patients
Orexo’s most advanced product candidate is Rapinyl™, which is designed for rapid, effective and safe treatment of acute pain. Rapinyl™ is based on Orexo’s sublingual technology and contains the pain-relieving substance fentanyl. The primary indication for Rapinyl™ is acute breakthrough pain in cancer patients. Around 80 percent of patients suffering from cancer-related pain suffer at times from acute pain, so-called breakthrough pain (Wood Mackenzie 2004). Treatment of this type of pain is currently dominated by conventional tablets and mixtures containing morphine. For some time, a fentanyl-containing “lollipop� has also been available.
The advantage of the Rapinylâ„¢ tablet is that it rapidly disintegrates into ordered units of carriers that adhere to the sublingual mucosa and the active compound dissolves. This allows the drug to rapidly and effectively permeate the sublingual mucosa to enter the bloodstream. The result is a quicker and more predictable onset of action than with products that must be ingested in order for the drug to enter the bloodstream by passing through the stomach and being absorbed further down the intestinal tract.
Patents
The technology behind Rapinylâ„¢ is protected by patents in the US, Europe and Japan.
Project status
Rapinylâ„¢ for the treatment of acute pain is in Phase III in the US and in registration phase in Europe.
Endo Pharmaceuticals informed the stock market that it expect to file NDA in the second half of 2007.
Licensing
Licensing agreements for Rapinylâ„¢ have been signed with Endo Pharmaceuticals for the North American market, ProStrakan Group plc for the European market and with Kyowa Hakko for the Japanese market.
Orexo´s ambition is to sign a licensing agreement for the rest of the world, where a licensing agreement has not been signed, during the second half of 2006.
