PEPTONIC medical today announced that it has completed the evaluation of different tube models and materials for use as primary packaging of VAGITOCIN® – the company’s oxytocin based gel in development for the treatment of vaginal atrophy. As a result of the 6-month stability tests, two tube variants have been found to meet the requirements […]
PEPTONIC medical today announced that the last patient participating in the VAGITOCIN® pharmacokinetic (PK) study has been discharged after a final visit to the physician in accordance with the study protocol. The study has been carried out according to plan. Blood samples taken from the study subjects will be analysed at a laboratory in Gothenburg, […]
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 […]
PEPONIC medical has signed an agreement with Destum Partners in USA for support in finding suitable collaboration partners. By using a US based consulting company the process to find collaboration partners in USA may be significantly facilitated. North America is the most important market for pharmaceuticals in the world. The collaboration with the mentioned company […]
PEPTONIC has started a collaboration with Clinartis in USA. Clinartis is a consulting company within the clinical/regulatory area. They support us in the work with planning of a so called pre-IND meeting with FDA (Food and Drug Administration). This meeting will help us in designing the phase III study and will also guide us for […]
A regulatory/scientific, advisory meeting has been performed at the MPA on the 25.3.13. The results from the recently concluded clinical study and the design of the planned phase III were discussed. The advice from the MPA is not binding but gives a valuable direction how to continue the work. They were satisfied with our plans.
A new formulation patent for oxytocin was approved by the Swedish patent authorities in February 2013. PEPTONIC has received a patent on the new formulation of Vagitocin. Sweden was the first country for submission of this patent. It was approved without any objections. A PCT application is now presented for patent rights in e.g. Europe, […]