CAM2038

• Easy and convenient administration • Improved treatment adherence • Adapted to prefilled syringes and autoinjectors • Long-acting drug release • Small injection volume with a thin needle • Good safety profile • Manufacturing by standard processes • Improved treatment adherence • Reduced frequency of administrations – from 365 times to 12 times per year • Minimized risk of diversion and misuse • Eliminates risk of accidental pediatric exposure • Flexible dosing and adjustable duration allow individualized therapy in all treatment phases • Blocks the effects of illicit opioids

CAM2038 includes two long-acting subcutaneous buprenorphine investigational products for treatment of opioid dependence. The product candidates are based on Camurus’ proprietary FluidCrystal® injection depot technology and are intended for either weekly (q1w) or monthly (q4w) administration, each in multiple doses to allow individualized treatment of patients with opioid dependence. CAM2038 has the potential to free patients from the burden and stigma associated with the daily, often supervised, distribution and administration of medication.

The investigational products will be provided in prefilled syringes with thin needles, designed for convenient administration by healthcare personnel to ensure proper delivery and treatment compliance, and to minimize the risks of diversion, abuse, misuse, and accidental pediatric exposure. By reduced dosing frequency and thereby costs of treatment under supervision, as well as by improved treatment compliance, CAM2038 also has the potential to generate substantial savings for healthcare and society.

Camurus’ FluidCrystal® technologies are all based on special combinations of endogenous polar lipids that spontaneously form liquid crystal nanostructures in aqueous environments; at tissue surfaces or in the body. By combining these with active ingredients with proven efficacy and safety profiles, new patented medicines are developed at significantly lower cost and risk, compared with the development of new medicines.

Camurus’ FluidCrystal® injection depot is designed to provide treatment efficacy over extended periods – from days to months – with a single injection. It has the potential to reduce the burden of daily medication while increasing adherence to therapy. FluidCrystal® is suitable for biological peptides as well as small molecules.

The FluidCrystal® injection depot comprises a lipid-based liquid with a dissolved active ingredient that can easily be injected subcutaneously using a conventional syringe with a thin needle. Upon contact with fluids in the tissue, the lipid solution transforms into a liquid crystalline gel, which effectively encapsulates the active ingredient. The drug compound is slowly released as the liquid crystalline matrix gradually degrade in the tissue and the release can be controlled from several days to weeks or months depending on the composition. The system’s simplicity, including a spontaneous self-association to a functional structure in the body, eliminates complicated manufacturing procedures and the need for mixing prior to administration. Medicines based on the FluidCrystal® injection depot has the potential to be administered by the patients themselves or by healthcare professionals, without time-consuming and complicated reconstitution procedures. The long-acting drug release aims to reduce the patient’s burden of administering medication daily, improve the adherence to and results of the treatment, and improve the patient’s quality of life.