An FDA advisory panel ruled yesterday that the benefits of Endo Pharmaceutical‘s opioid painkiller, Opana ER, no longer outweigh its risks. The painkiller has been linked to a 2015 HIV outbreak in Indiana after people addicted to opioids shared needles while injecting Opana. The panel voted 18 to 8 that the drug’s benefits do not […]
Endo Pharmaceuticals
Endo cuts staff in restructuring effort
Endo International (NSDQ:ENDP) said today that it will cut 90 full-time positions from its workforce in an effort to restructure its generics and U.S. branded pharmaceutical businesses. The company said it will invest part of the cost savings that result from its restructuring into Endo’s core products and new product development. “Last year, Endo completed […]
BioDelivery’s topical gel for diabetic neuropathy fails in phase IIb trial
BioDelivery Sciences International (NSDQ:BDSI) said today that its clonidine topical gel for pain relief in patients with diabetic neuropathy failed in a phase IIb clinical trial. Raleigh, N.C.-based BioDelivery will halt any further development of the painkiller. In the phase IIb clinical trial, BioDelivery’s topical gel did not demonstrate a statistically significant difference in pain relief […]
BioDelivery reacquires license to buprenorphine film
BioDelivery Sciences International (NSDQ:BDSI) said today that it reacquired the license to the Belbuca (buprenorphine) buccal film from Endo Pharmaceuticals. Malvern, Penn-based Endo Pharmaceuticals licensed the worldwide manufacturing and marketing rights to the opioid patch from BioDelivery in 2012. Belbuca, a once-daily opioid, is indicated for the management of severe pain. The small, peppermint-flavored film works by […]
Scilex touts data for novel lidocaine patch
Sorrento Therapeutics (NSDQ:SRNE) subsidiary Scilex Pharmaceuticals said today that its lidocaine patch, ZTlido, met primary and secondary endpoints in a pivotal study comparing the patch to Endo Pharmaceutical‘s Lidoderm patch. The data will be used to resubmit a new drug application to the FDA in mid-2017, the Malvern, Pa.-based company said. The clinical trial evaluated Scilex’s […]