LATITUDE’s internal product development activities focus on addressing areas of unmet medical need through formulation. These efforts include taking known drugs and making significantly safer, more stable and/or easier-to-use versions that also comprise new intellectual property.  Such re-formulations are designed to be eligible for the fast-track 505(b)(2) NDA, offering considerable time and cost savings for the licensor during FDA approval. LATITUDE’s currently available 505(b)(2) product candidates include:

Intra-V : a stable liquid, ready-to-use (RTU) intravenous formulation of the antibiotic vancomycin

Opti-V : a stable, liquid RTU, ophthalmic formulation of the antibiotic vancomycin

PumpaGon : a stable aqueous glucagon formulation suitable for a bihormonal insulin pump or artificial pancreas for prevention and treatment of hypoglycemia

PAC-E : a safer formulation of the anti-cancer drug paclitaxel (TAXOL®, ABRAXANE®) that shows significantly-reduced peripheral neuropathy, and which can be tolerated at a much higher dose than TAXOL®.

Nano-K : a stable, liquid, Cremophor®-free vitamin K formulation for preventing coagulation deficiencies in newborns or for treatment of dysmenorrhea (replacement for AquaMEPHYTON®).

Nano-A : a stable, polysorbate-free RTU amiodarone nanoemulsion for treating cardiac arrhythmias (replacement for Nexterone®)

24H Tramadol : a 24 hr release tablet for tramadol with proven in vitro release profile equivalent to Ultram® and Ryzolt®.

LATITUDE has also applied its formulation expertise to develop novel formulations of known drugs in new dosage formats:

• Diazepam (benzodiazepine for seizure rescue) for subcutaneous/intramuscular injection

• Celecoxib (NSAID COX-2 inhibitor) for intravenous injection

• Diclofenac (NSAID) for intravenous injection

• Insulin in an extended-release depot

• Progesterone for intravenous injection

For further information on these Licensing Opportunities, click here.