Cancer patients in the UK experiencing ‘breakthrough’ pain have gained access to a new means of reducing their discomfort following yesterday’s nationwide launch of Nycomed’s first-in-class nasal spray Instanyl.

Breakthrough cancer pain is basically a severe bout of pain that breaks through continuous background pain medication, the onset of which is sudden and typically last for up to 30 minutes. The condition affects 95% of all patients experiencing chronic cancer pain, and its severity and unpredictability can have a significant impact on quality of life.

To date, breakthrough cancer pain has been treated with oral opioids but, as the company points out, these take 20-30 minutes to take work - at which point the episode may be approaching its end - and the effects also last for three to six hours afterwards.

Instanyl (fentanyl) has been designed to address these shortcomings by offering fast absorption and “meaningful” pain relief within ten minutes of administration and a short duration of effect to minimise patients’ drug exposure in an easy-to-use format, the company said.

The drug received a license in Europe in July this year after Phase III clinical trials showed that 58% of patients experienced clinically significant pain relief just 10 minutes after taking Instanyl, and that all doses were well tolerated during a 10-month follow-up.

Furthermore, in a multinational cross-over study comparing Nycomed’s drug with oral transmucosal fentanyl citrate (OTFC), 25% of episodes treated with Instanyl showed a 33% reduction in pain intensity after just five minutes compared to 7% with OTFC, and 51% had meaningful pain relief at 10 minutes versus 24%, respectively.

In addition, a spokeswoman for Nycomed told PharmaTimes UK News that the National Health Service list price of Instanyl is £5.95 per dose for all dose strengths, which, she stressed, is parity to Cephalon's OTFC Actiq.

According to Dr Andrew Davies, Consultant in Palliative Medicine at the Royal Marsden NHS Foundation Trust, Surrey, Instanyl represents “a major advance in the management of breakthrough pain, with clinical studies demonstrating ease of use, a rapid onset of action, a high level of pain relief, and [that it] is well tolerated”.

While the product is the first nasal spray to reach the market for breakthrough cancer pain others are also in development and could pose some serious competition to Instanyl if regulatory clearance is gained.

Competition on the horizon?
UK group Archimedes is currently working on NasalFent, an aqueous fentanyl citrate nasal spray built with the group’s proprietary PecSys technology, which is also attracting attention because of its powerful and fast action.

Phase III trials of the product, which has been filed with European regulators for approval, have also demonstrated that patients experience a significant reduction in pain within 10 minutes of administration.

And according to Archimeds, the PecSys technology behind the product improves on standard nasal sprays as it generates the formation of a thin layer of gel in the nostril that modulates drug absorption so that pain relief is delivered in a rapid but controlled manner, thereby increasing its duration of action.

Furthermore, it claims that it also helps to avoid common problems such as the dripping/swallowing of the drug or sub-therapeutic levels often seen with conventional nasal sprays.