Positive Phase II for intranasal antiemetic

Many patients receiving chemotherapy suffer from nausea and vomiting, which has created a market for antiemetic treatments. More recently research has focused on improving convenience and compliance by using alternative formulations, such as transdermal or intranasal.

SNBL’s intranasal formulation of granisetron (TRG) appears to have pharmacokinetics and efficacy comparable to the intravenous version. In addition it makes self dosing more reliable and easier than either intravenous or oral formulations, according to the company.

Some cancer patients have difficulty swallowing, reducing the convenience of oral administration and TRG is expected to be particular appealing to this group.

SNBL believes the global satisfaction assessments from the double-blind Phase II trials, which were conducted at 14 specialist cancer centres in the US, support this viewpoint.

The satisfaction assessments for the various strengths of TRG, 0.5mg, 1mg and 2mg, were around 80 per cent and upwards. Patients treated with 2mg TRG had a 96.6 per cent satisfaction assessment, the highest of all the dosages.

Furthermore, the Phase II trial appears to have shown that TRG does not cause nasal discomfort, burning, itching or have a bad taste at 30 minutes, four hours or 24 hours after dosing. This supports the favourable safety profile of TRG, according to SNBL.

Having obtained these positive results SNBL has initiated business development and negotiations for the out-licensing of TRG, according to a company spokesman. SNBL has said any progress relating to out-licensing will be reported in a timely manner.

Following the success of Phase II, SNBL believes that a Phase III trial is justified.