Nausea and Vomiting of Pregnancy (NVP) affects ~53% of women


Nausea and Vomiting of Pregnancy (NVP), commonly known as, “morning sickness” may be much more severe than the name suggests: 80% of women have prospectively reported their symptoms of NVP to last throughout the entire day. The onset of NVP is typically within 4 weeks of the last menstrual period, peaking at ~9 weeks gestation and resolving at ~20 weeks. In some severe cases, women may experience NVP throughout their entire pregnancy. Factors associated with reduced NVP severity include advanced age, multiparity, smoking (attributed to reduced placental volume), and lower hCG levels.

Current Treatment

The initial approach in managing NVP is to make dietary changes including the avoidance of trigger odors and foods. If that approach does not resolve symptoms on its own, guidance recommends the addition of pharmacotherapy. A combination pill of doxylamine and pyridoxine, currently marketed under the brand name Diclegis®/Diclectin® is the first-line treatment for NVP. It has been associated with greater than 70% reduction in nausea and vomiting in controlled trials and is supported by extensive fetal safety data.

Unmet Medical Needs

Thirty-four percent of AQS-surveyed mothers (64/205) were prescribed prescription medication to manage nausea and vomiting during their pregnancy; ~75% of those women indicated the severity of their symptoms to be at least 8/10, or “extreme nausea”. Doxylamine-pyridoxine is the first-line agent for the management of NVP. It is currently administered with a dosing frequency up to four times per day, creating opportunities to miss doses and suffer from breakthrough increases in NVP symptoms. Once-weekly dosing will provide steady-state delivery and alleviate between-dose NVP symptoms. 

In addition, taking an oral medication is challenging while suffering from uncomfortable nausea. The uncertainty that results from vomiting within a short time after dosing, whether taking another dose would be permissible, can be alleviated by transdermal administration of the medication.