We have a diversified drug development pipeline across two therapeutic categories - oncology and CNS.
GTP-011 is a 72-hour patch for which a patent application has been filed by GTP for the prevention of motion sickness, a well-known syndrome that typically involves nausea and vomiting in otherwise healthy people and that occurs upon exposure to certain types of motion.
Currently, the scopolamine patch (Transderm Scop® from Novartis) is viewed as a first-line medication for prevention of motion sickness (Gil et al., 2012; Brainard and Gresham, 2014). However, side effects can be of particular concern and include sedation (Spinks et al., 2004), reduced memory for new information, impaired attention, and lowered feelings of alertness (Parrott, 1989). Mental confusion or delirium can occur after application of scopolamine patch (Seo et al., 2009). Elderly people as well as people with undetected incipient dementia or mild cognitive impairment, or MCI, may be particularly prone to develop mental confusion after applying the scopolamine patch (Seo et al., 2009).
GTP-011, like scopolamine, is a patch that contains a muscarinic receptor antagonist. Unlike scopolamine, however, it has been reported not to affect memory and cognition and has a low incidence of sedation (Kay et al., 2012). GTP-011 may thus be a safer alternative to the scopolamine patch for the treatment of motion sickness.
Since GTP-011 is a new patch of an approved drug, we anticipate that the NDA will be a 505(B)2 NDA. We expect to complete a proof-of-concept clinical trial for GTP-011 in the first half of 2018.