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तार समाचार

महिला यौन रुचि / उत्तेजना विकार (FSIAD) के लिए नया परीक्षण

द्वारा लिखित संपादक

Freya Pharma Solutions today announced to have secured US$XNUMX million in new funding from existing and new investors. The new funding will be used to carry out a pivotal phase XNUMX trial with its therapy Lybrido in XNUMX patients across Europe. Previously, Lybrido showed clinical relevance and statistical significance in a phase XNUMXb clinical trial, clearly meeting the primary endpoints. The phase XNUMX trial will start in the second half of XNUMX, with interim results expected by the second half of XNUMX.

Upcoming pivotal phase XNUMX trial

Freya Pharma Solutions plans to conduct the pivotal phase XNUMX clinical trial to confirm the efficacy of Lybrido in women suffering from female sexual interest/arousal disorder (FSIAD). Clinical research Organization CRXNUMXO BV (www.CRXNUMXO.nl) is leading the preparation, execution and reporting of this Phase XNUMX clinical trial. CRXNUMXO is a full-service clinical contract research organization aimed at developing innovative treatments for unmet medical needs.

Previous pre-clinical and clinical studies, manufacturing and development of Lybrido were performed according to EU GLP, GMP and GCP regulations.

It is anticipated that a Scientific Advice Meeting with the EMA will be held before commencement of the phase XNUMX trial. The main objective of that meeting would be to confirm acceptability of the phase XNUMX trial design protocol, as well as the overall clinical development strategy.

The phase XNUMX clinical trial will be conducted within the European Union in accordance with Good Clinical Practices and the ethical principles stated in the Declaration of Helsinki. It will comply with the EU Clinical Trial Regulation (No. XNUMX/XNUMX), all other applicable laws and regulations, as well as requirements of applicable Member States where the study is undertaken.

Marcel Wijma, Executive Director of Freya Pharma Solutions comments, “We’re delighted with the trust and confidence from our existing and new shareholders in the chances of advancing this groundbreaking therapy for women with FSIAD to the market in due course. And we’re fully committed to bringing a therapy for FSIAD to a great number of patients around the world suffering from this distressing disorder.”

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