SUD-002 : nausea

SUD-002 is a first-in-class mint-flavoured oral spray formulation of ondansetron (marketed in tablet form by GlaxoSmithKline under the brand name Zofran®), the most commonly prescribed antiemetic to treat nausea and vomiting induced by chemotherapy or radiotherapy and also other post-operative settings.

SUD-002 achieves therapeutic drug levels by delivering a micro-mist of concentrated ondansetron over the oral mucosa and may offer a desirable alternative to patients requiring antiemetic therapy who have difficulty in swallowing.

The product has been evaluated in over 300 patients in multiple clinical trials. These included four randomized studies in which the pharmacokinetics (PK) of 8mg of SUD-002 was compared with 8mg ondansetron tablet in about 100 subjects, including both men and women. Both gender group received the two treatments and were included in the PK analyses.

The studies successfully demonstrated that SUD-002 8mg dose was statistically bioequivalent to the current commercially available 8mg ondansetron tablet, was well tolerated and can be conveniently administered in multiple doses. In addition, SUD-002 delivered statistically faster absorption as defined by median time to detectible drug levels of ondansetron at 15 minutes versus 30 minutes for the tablet.

The most commonly reported adverse events (AEs) after treatment with SUD-002 compared with those for the tablet for all women/men were headache (14%/14% SUD-002; 27%/10% tablet) and dizziness (5%/5% SUD-002; 0%/10% tablet). The incidence of all other AEs was ≤ 5%, and there were no serious or unexpected AEs.

Details of these results were presented in 2006 at the American Society of Clinical Oncology’s (ASCO) Annual Meeting.

The global anti-emetics market is estimated to reach US$3.6bn in 2015 from US$2.5bn in 2010.

If you are interested to learn more about SUD-002 please email This email address is being protected from spambots. You need JavaScript enabled to view it. (Chief Business Officer).