Journey Medical

AZ - Scottsdale

Biotechnology1 H-1B visas (FY2023)

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Focus: Skin Treatments

Journey Medical is a life sciences company focused on Skin Treatments.

Dermatology

Open Jobs

Products & Portfolio (7)

2 discontinued products not shown

AMZEEQ

minocycline

Peak

SMTOPICAL · AEROSOL, FOAM

12.1 Mechanism of Action The mechanism of action of AMZEEQ for the treatment of acne is unknown. 12.2 Pharmacodynamics The pharmacodynamics of AMZEEQ for the treatment of acne are unknown. 12.3 Pharmacokinetics In a pharmacokinetic study, male and female subjects 18 years of age or older with acne vulgaris (N=30) applied approximately 4 grams of AMZEEQ topically to the face, neck, upper chest, upper back, shoulder and upper arms once daily for 21 days. The mean ± SD C max and AUC 0-24h were 1.3 ± 0.6 ng/mL and 23.0 ± 10.8 ng·h/mL, respectively at Day 21 for AMZEEQ. After daily application of AMZEEQ in subjects with acne for 21 days, steady-state was reached by Day 6 and systemic accumulation of minocycline was not evident. Specific Populations Age: Pediatric Population Pharmacokinetics of minocycline was evaluated in 20 subjects 10 years to less than 17 years of age with acne vulgaris following application of approximately 4 grams of AMZEEQ topically to the face, neck, upper chest, upper back, shoulder and upper arms once daily for 7 days. Minocycline was detected in all samples obtained on Day 7. Pharmacokinetic results are presented by age group in . The overall pediatric population showed 2.4-fold and 2.7-fold higher C max and AUC 0-24h compared to the adult population. Table 2: Clinical Pharmacokinetics of Minocycline when treated with AMZEEQ (~4 g) in Pediatric Subjects Aged 10 to <17 years with Acne Vulgaris Age Group (years) Mean ± SD C max (ng/mL) Mean ± SD AUC 0-24h (ng·h/mL) 10 - 11 4.5 ± 4.0 90.9 ± 90.2 12 - 14 2.8 ± 2.2 54.0 ± 46.2 15 - <17 2.0 ± 1.2 40.8 ± 23.8 10 - <17 3.1 ± 2.7 61.1 ± 59.2 12.4 Microbiology Resistance Propionibacterium acnes strains displayed a low propensity for the development of resistance to minocycline, with spontaneous mutation frequencies being <10 at 2 to 16 × MIC. Antimicrobial Activity Minocycline is active in vitro against most isolates of Propionibacterium acnes ; however, the clinical significance is unknown.

inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of ageolderdevelopment of drug-resistant bacteria+1 more

2019

EMROSI

minocycline hydrochloride extended-release

Growth

ORAL · CAPSULE, EXTENDED RELEASE

12.1 Mechanism of Action The mechanism of action of EMROSI for the treatment of rosacea is unknown. 12.2 Pharmacodynamics The pharmacodynamics of EMROSI for the treatment of rosacea are unknown. 12.3 Pharmacokinetics EMROSI is not bioequivalent to any other minocycline products. The pharmacokinetics of minocycline following administration of EMROSI was investigated in two studies that enrolled 32 healthy, adult subjects. In Study 1, the plasma pharmacokinetic parameters for EMROSI following single dose administration under fasting and fed states are presented in . Table 1: Plasma Pharmacokinetic Parameters [Mean (%CV)] for EMROSI (40 mg) N C max (ng/mL) T max * (hr) AUC inf (ng.hr/mL) t 1/2 (hr) EMROSI (Fasting) 23 243.9 (37.3) 1.50 (1.00 – 4.17) 3933.6 (31.2) 14.67 (26.7) EMROSI (Fed) 23 225.0 (16.7) 4.50 (3.00 – 8.00) 4404.1 (21.0) 14.93 (21.5) Note: * Median (Range) In Study 2, minocycline plasma PK following EMROSI single (Day 1) and after repeated (Day 21) once daily administrations in eight (8) subjects were found to be similar with overlapping ranges. The mean C max was 382.83 ng/mL versus 337.74 ng/mL and AUC 0-24 was 3549.64 ng*hr/mL versus 3957.62 ng*hr/mL, respectively on Day 1 versus Day 21. Absorption: In Study 1, the median plasma T max of minocycline from EMROSI was 1.50 hours (1.00 - 4.17). In Study 2, the median plasma T max values of minocycline from EMROSI on Day 1 and Day 21 were 1.75 and 1.5 hours, respectively. Effect of Food: Following administration of EMROSI with a high-fat meal (1011 Kcal, 53% fat), T max was delayed by approximately 3 hours. The high fat meal did not impact the C max however, the AUC inf was increased by 15.26% ( ) [see ]. Distribution: Minocycline is lipid soluble and distributes into the skin and sebum. In Study 1, the mean apparent volume of distribution (Vz/F) values of minocycline following oral administration of EMROSI at fasting and fed condition were 229.61 (±67.83) L and 199.83 (±43.71) L, respectively. Elimination: The mean apparent elimination half-life (t ½ ) of minocycline from EMROSI was approximately 15 hours independent of fasting and fed dosing condition.

inflammatory lesions (papulespustules) of rosacea in adultsdevelopment of drug-resistant bacteria+2 more

CLINICAL PHARMACOLOGY: Pruradik lotion has scabicial and antipruritic actions. The mechanisms of these actions are not known. The pharmacokinetics of crotamiton and its degree of systemic absorption following topical application have not been determined.

CLINICAL PHARMACOLOGY Sulconazole nitrate is an imidazole derivative that inhibits the growth of the common pathogenic dermatophytes including Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis. It also inhibits the organism responsible for tinea versicolor, Malassezia furfur, and certain gram-positive bacteria. A maximization test with sulconazole nitrate solution showed no evidence of irritation or contact sensitization.

tinea cruristinea corporis caused by Trichophyton rubrumTrichophyton mentagrophytes+2 more

CLINICAL PHARMACOLOGY Sulconazole nitrate is an imidazole derivative with broad-spectrum antifungal activity that inhibits the growth in vitro of the common pathogenic dermatophytes including Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis. It also inhibits (in vitro) the organism responsible for tinea versicolor, Malassezia furfur. Sulconazole nitrate has been shown to be active in vitro against the following microorganisms, although clinical efficacy has not been established: Candida albicans and certain gram-positive bacteria. A modified Draize test showed no allergic contact dermatitis and a phototoxicity study showed no phototoxic or photoallergic reaction to sulconazole nitrate cream. Maximization tests with sulconazole nitrate cream showed no evidence of contact sensitization or irritation.

tinea pedis (athlete's foot)tinea cruristinea corporis caused by Trichophyton rubrum+4 more

SMTOPICAL · AEROSOL, FOAM

2020

Open Jobs (1)

TERRITORY MANAGER

New Orleans, LA

Sales

1mo ago

Interview Prep Quick Facts

Portfolio: 9 approved products

Top TAs: Dermatology

H-1B (2023): 1 approval

Open Roles: 1 active job

Portfolio Health

Growth1 (11%)

Peak3 (33%)

LOE Approaching5 (56%)

9 total products

Therapeutic Area Focus

Dermatology

1 marketed

Marketed

Pipeline

Visa Sponsorship

Sponsors Work Visas

H-1B Petitions (FY2023)

Approved

Denied

100%

Rate

Source: USCIS H-1B Employer Data Hub