• Alkermes plc, of Dublin, Ireland, said results from a Phase I/II study in major depressive disorder (MDD) showed that AKLS 5461 significantly reduced depressive symptoms, as measured by the Hamilton Depression Rating Scale. MDD patients received the drug, a combination of buprenorphine and opioid modulator ALKS 33, for a seven-day treatment period. Results also showed that ALKS 5461 was generally well tolerated. Data were presented at the New Clinical Drug Evaluation Unit meeting in Phoenix.

• Celsion Corp., of Lawrenceville, N.J., said it reached its enrollment objective of 700 patients in its Phase III HEAT study of ThermoDox in combination with radiofrequency ablation in hepatocellular carcinoma. The primary endpoint is progression-free survival. ThermoDox is a heat-activated liposomal encapsulation of doxorubicin.

• Flexion Therapeutics Inc., of Woburn, Mass., said lead osteoarthritis candidate FX005, a p38 MAP kinase inhibitor, demonstrated significant pain relief over placebo at four weeks in a Phase II trial. Top-line data showed that FX005, delivered intra-articularly to the knee, was well tolerated and resulted in prolonged improvement in joint pain and function throughout the 12-week duration of the study. The trial enrolled 104 patients.

• Repros Therapeutics Inc., of The Woodlands, Texas, said the FDA advised the firm it must complete an integrated safety analysis of completed studies of oral Proellex and submit a report for review prior to any additional trials testing oral administration of telapristone acetate, Proellex's active ingredient. Repros said it plans to submit the document over the next few weeks. The FDA has committed to reviewing the findings within 30 days to allow a potential continuation of the low-dose oral program. The firm intends to start a Phase II/III study in endometriosis, if allowed.

• Zogenix Inc., of San Diego, said it submitted an investigational new drug application for Relday, a combination of the firm's DosePro needle-free, subcutaneous drug delivery system plus a subcutaneous once-monthly formulation of risperidone for treating schizophrenia. Initial trials are planned to start in the second half of this year, with results expected by year-end.