FDA Receives Slew of New Drug Applications for Bipolar Disorder, Opioid Disorder and Rare Disease



Several biopharmaceutical companies have submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) in recent weeks, covering treatment indications ranging from an opioid overdose to bipolar disorder and rare disease. 

Adamis Pharmaceuticals

The first in the lineup is Adamis Pharmaceuticals, which on Monday resubmitted an NDA to the FDA for ZIMHI™, the company’s naloxone injection candidate designed to treat opioid overdose. The resubmission of the application was based on feedback from the FDA received during a Type A meeting in April. While the company didn’t fully disclose the agency's concerns regarding the initial NDA, Adamis says it expects it has attended to these concerns in the new application. 

Kinnate Biopharma

Also on Monday was an announcement made by Kinnate Biopharma, which detailed the FDA’s clearance of the company’s Investigational NDA for KIN-2787. With the clearance, Kinnate says it anticipates to soon begin studying the therapy in a first-in-human Phase I clinical trial for mutant BRAF-driven solid tumors. 

The company also said it sees hope for its lead FGFR inhibitor candidate, KIN-3248, for urothelial tumors or intrahepatic cholangiocarcinoma and anticipates filing an Investigational NDA for this therapy in the first half of next year.

Cyclo Therapeutics

Cyclo Therapeutics said that the FDA had provided feedback for an NDA for a Phase II study of Trappsol® Cyclo™ in early Alzheimer’s disease. The company looks to advance the Phase II asset towards an NDA in the second quarter of this year. 

In a statement on the NDA feedback, Cyclo Therapeutics noted that topline data from a Phase I/II clinical trial showed Trappsol® Cyclo™ featured a promising safety and efficacy profile in Niemann-Pick Disease Type C (NPC). The company said it plans to start enrollment and dosing of NPC therapy in a pivotal Phase III study. 

Kiromic Biopharma

Houston-based Kiromic Biopharma submitted on Monday a novel Investigational NDA to the FDA for an early-stage trial for a potential universal T-cell therapy for solid malignancies expressing PD-L1. 

The Phase I trial will be an open-label, dose escalation study of KB-PD1, the company’s allogeneic gamma delta T-cell expressing a chimeric PD1 switch receptor. The therapy has been designed to block the PD1/PD-L1 interaction, similar to a checkpoint inhibitor, as well as “rewire” this blocking action “into an accelerator,” according to a statement made by the company.

BioXcel Therapeutics

On Wednesday, BioXcel Therapeutics recently received NDA filing acceptance from the FDA for BXCL501, an orally dissolving thin film dexmedetomidine formulation, for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II. 

The filing included data from randomized, placebo-controlled Phase III studies, including the SERENITY I & SERENITY II. These studies showed BXCL501 was generally well-tolerated by patients and significantly improved agitation over a long-term period.

Strongbridge Biopharma

Last week, the global commercial-stage biopharmaceutical company Strongbridge Biopharma also announced the FDA accepted the filing of an NDA for RECORLEV® (levoketoconazole) for endogenous Cushing’s syndrome. 

The company said it had received a Day 74 letter from the FDA earlier than anticipated, with the agency stating it has projected a 10-month review period for the drug. Data from the Phase III SONICS and LOGICS trials supported the NDA filing. These data showed significant benefits of RECORLEV in endogenous Cushing’s syndrome, as well as promising safety.

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