PEPTONIC medical today announced that it met with the US Food and Drug Administration (FDA) earlier this month in a so called pre-IND meeting. The objectives of the meeting were to obtain FDA’s view on the clinical documentation generated to date and to seek advice regarding the continued clinical development of VAGITOCIN® towards a marketing approval in the USA.
The meeting was attended by Dan Markusson, Kerstin Uvnäs Moberg and Christer Sjögren from PEPTONIC and by staff of Clinartis, Inc., the regulatory adviser of PEPTONIC in the USA.
About PEPTONIC medical
PEPTONIC medical is an innovative Swedish pharmaceutical company developing oxytocin based products e.g. for the treatment of menopausal symptoms, such as vaginal atrophy. PEPTONIC medical’s mission is to develop safe and effective drugs based on the well-known beneficial properties of oxytocin.
About vaginal atrophy
In conjunction with menopause, many women develop vaginal atrophy. It is the decreasing estrogen levels occurring during menopause that results in vaginal atrophy, as estrogen stimulates the growth of the mucosa. Symptoms such as vaginal dryness, irritation and itching are common in women with vaginal atrophy. The risk of developing infection is increased and sexual intercourse can be painful which affects sex life negatively.
Frequently these problems can be improved by means of estrogen treatment in the form of tablets, patches or local treatment with creams or vaginal inserts. However, not all women can or are willing to use estrogen. PEPTONIC’s Vagitocin ®, which contains oxytocin, offers an alternative to estrogen.
Vagitocin® is a pharmaceutical preparation for the treatment of vaginal atrophy. The product is based on oxytocin, a natural substance, which is produced in the body and which has been used to promote labour and breast-feeding since the beginning of the 1960ies. Local application of Vagitocin® in the vagina has been shown to rejuvenate the vaginal mucosa.
Oxytocin is a peptide hormone that is produced in the brain. It is well known for its hormonal actions in conjunction with birth and breast feeding, as it stimulates contractions of the womb during the labour and helps eject the milk during breast-feeding. It has been used clinically since the 1960’ies and is applied as injections, drip or nasal spray.
Oxytocin is the active ingredient of Vagitocin®. The oxytocin gel is administered in the vagina to exert local healing effects on the vaginal mucosa. Oxytocin has a long history of safe and effective medical use and offers an alternative to estrogen and estrogen-like acting compounds for menopausal and postmenopausal women.
For more information, please contact:
Dan Markusson, CEO
+46 768 550 200