Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

BioXell overactive bladder drug stops going: Top-line results from a European Phase IIb study of BioXell's OAB drug elocalcitol show the drug failed to demonstrate a statistically significant effect on the primary endpoint of change in volume at first involuntary contraction following four weeks of treatment, the Milan, Italy-based Roche spinoff announced April 8. The study involved 257 patients randomized to placebo, 75 mcg or 150 mcg elocalcitol. Results were mixed on secondary endpoints: in the intent-to-treat population, a significant improvement was observed in bladder volume at first desire to void, along with significant improvement in incontinence episodes in the modified ITT population. Numerical improvements were seen for OAB symptoms in all treatment groups, with a strong dose-related trend in patient's perception of bladder condition in the ITT population that reached statistical significance in the per protocol analysis. The company immediately put development of another candidate, BXL746, for post-surgical adhesions, and a Phase II study of elocalcitol in male infertility on hold while it assesses options

You may also be interested in...

Cephalon’s Nuvigil On Course For Jet-Lag Filing

Wakefulness drug completes Phase III with flying colors and targets tricky $100M market.

Gout Pipeline Looks Past Uloric To Resistant Patients, Acute Flares

Takeda’s Uloric (febuxostat) ended a forty-year drought for new gout treatments when FDA approved the oral drug for chronic disease on Feb. 13, but a pipeline stocked with new drugs holds the promise of a shorter wait for the next gout therapy.

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts