GTP-011 is a 72-hour patch patented by GT Pharmaceuticals 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. Children and women are most susceptible to motion sickness (Schmäl, 2013). Estimates of the prevalence of motion sickness vary from 9% to 38%, depending on the studies (Koslucher et al., 2015).
The scopolamine patch (Transderm Scopâ 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 comprise 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 (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 does not affect memory and cognition and has a low incidence of sedation. 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, Management anticipates that the NDA will be a 505(b)2 NDA.