generic isotretinoin in the fed state.15,23 The study included 925 patients with severe recalcitrant nodular acne who were randomized 1:1 to receive Absorica or a generic traditional oral isotretinoin capsule. The two primary endpoints of the study included the change in total nodular facial and truncal lesion count from baseline to 5 months, and the percentage of patients reporting at least 90 percent reduction in nodular facial and truncal lesion count from baseline to 5 months. The efficacy of Absorica and generic isotretinoin were comparable; the change in nodular lesion count from baseline was -15.68 and -15.62 for patients taking Absorica or generic isotretinoin, respectively.15,23 In addition, 70 percent of patients taking Absorica and 75 percent of patients taking generic isotretinoin achieved at least 90 percent reduction in nodular facial and truncal lesion count from baseline.15,23
Food Effects
As previously mentioned, the absorption levels of Absorica LD are less dependent on food intake compared to other forms of oral isotretinoin. This improvement in absorption addresses the critical issue of patient adherence with concomitant ingestion of oral isotretinoin with food or a specified meal. Because isotretinoin is a highly lipophilic compound, its gastrointestinal absorption is enhanced by solubilization by dietary fat.6 Traditional oral isotretinoin formulations show a stark decrease in plasma levels in the fasted state compared to the fed state.8 Therefore, traditional formulations of isotretinoin are recommended to be taken with food, preferably a high-fat, high-calorie meal.8 However, adolescents and young adults, the main recipients of acne treatment, tend to have inconsistent eating behaviors. This irregularity of food consumption can influence gastrointestinal absorption of oral isotretinoin after ingestion.
The irregularity of food consumption is particularly prevalent among adolescents. Many adolescents frequently skip meals, most commonly breakfast. In a survey of 1,001 high school students with a mean age of 16.1 years, 59 percent indicated they skipped breakfast more than 3 times the previous week.24 In another national report, 30 percent of students aged 15 to 18 years skipped breakfast on any given day.25 Common reasons cited for skipping breakfast included lack of time, lack of hunger, or dieting to lose weight.25 In a survey obtained from adolescents taking isotretinoin, 71 percent report actually ingesting isotretinoin with food.26 The current diet fad of intermittent fasting has many adults skipping breakfast as well.
Furthermore, adolescents are unlikely to consume the recommended fat and calorie amounts as outlined by the FDA-stipulated meal. The FDA offered guidance to industry suggesting that meal studies to evaluate bioavailability and bioequivalence utilize a high-fat (50 percent of total caloric intake) and high-calorie (800 to 1000 calories) meal; the meal should include approximately 50 grams of fat.9 In a survey of adolescents using oral isotretinoin, the average fat grams ingested with oral isotretinoin was 18 grams (low 2g; high 53g; median 16g) and average calories ingested with oral isotretinoin was 483 calories (low 48 calories; high 1,220 calories; median 444 calories).26 Only 3 percent of patients in the survey report actually ingesting oral isotretinoin with a high-fat meal.26
The aforementioned data demonstrate that it is likely not realistic to expect patients on oral isotretinoin to consistently take the medications with the FDA recommended highcalorie and high-fat diets. Even if clear drug administration instructions are given and understood, patients may dismiss the instructions or forget them over the course of treatment, especially if not repeatedly emphasized. In addition, physicians may feel uncomfortable recommending such an unhealthy diet to their patients. By ingesting oral isotretinoin on an empty stomach or with a meal of insufficient fat or calories, patients may experience decreased absorption of the dose and fluctuations in drug plasma levels.5 Over time, this can lead to decreased cumulative exposure to isotretinoin therapy and impact therapeutic outcome, including long-term success.5 Patients who do not achieve the target cumulative dose are more likely to relapse and require subsequent courses of isotretinoin therapy.4,10,11
By eliminating the “food dependence†factor of oral isotretinoin, Absorica LD has the potential to improve patient adherence and achieve overall better therapeutic outcomes. Absorica LD achieves consistent serum levels irrespective of gastrointestinal contents.18 Because of this, adolescents and young adults, with their poor and irregular eating habits, will be relieved from planning doses around concomitant ingestion of food. Busy adults can also have inconsistent eating habits that have to adapt to varying work and personal life schedules, so they may also benefit from a treatment that is not food dependent. Importantly, diets that are either high in protein or low in calorie, which are not conducive for absorption of traditional isotretinoin, can be followed on Absorica LD without potential therapeutic consequence. Patients have the ability to engage in a healthier diet while on oral isotretinoin medication and still maintain adequate dose levels. Physicians can also recommend a healthier diet to their patients on Absorica LD, and they will no longer be obligated to continuously emphasize the importance of co-administration with food throughout the duration of treatment.
Safety Profile
Absorica LD is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients.15 Because of significant adverse reactions associated with its use, Absorica LD should
Food Effects
As previously mentioned, the absorption levels of Absorica LD are less dependent on food intake compared to other forms of oral isotretinoin. This improvement in absorption addresses the critical issue of patient adherence with concomitant ingestion of oral isotretinoin with food or a specified meal. Because isotretinoin is a highly lipophilic compound, its gastrointestinal absorption is enhanced by solubilization by dietary fat.6 Traditional oral isotretinoin formulations show a stark decrease in plasma levels in the fasted state compared to the fed state.8 Therefore, traditional formulations of isotretinoin are recommended to be taken with food, preferably a high-fat, high-calorie meal.8 However, adolescents and young adults, the main recipients of acne treatment, tend to have inconsistent eating behaviors. This irregularity of food consumption can influence gastrointestinal absorption of oral isotretinoin after ingestion.
The irregularity of food consumption is particularly prevalent among adolescents. Many adolescents frequently skip meals, most commonly breakfast. In a survey of 1,001 high school students with a mean age of 16.1 years, 59 percent indicated they skipped breakfast more than 3 times the previous week.24 In another national report, 30 percent of students aged 15 to 18 years skipped breakfast on any given day.25 Common reasons cited for skipping breakfast included lack of time, lack of hunger, or dieting to lose weight.25 In a survey obtained from adolescents taking isotretinoin, 71 percent report actually ingesting isotretinoin with food.26 The current diet fad of intermittent fasting has many adults skipping breakfast as well.
Furthermore, adolescents are unlikely to consume the recommended fat and calorie amounts as outlined by the FDA-stipulated meal. The FDA offered guidance to industry suggesting that meal studies to evaluate bioavailability and bioequivalence utilize a high-fat (50 percent of total caloric intake) and high-calorie (800 to 1000 calories) meal; the meal should include approximately 50 grams of fat.9 In a survey of adolescents using oral isotretinoin, the average fat grams ingested with oral isotretinoin was 18 grams (low 2g; high 53g; median 16g) and average calories ingested with oral isotretinoin was 483 calories (low 48 calories; high 1,220 calories; median 444 calories).26 Only 3 percent of patients in the survey report actually ingesting oral isotretinoin with a high-fat meal.26
The aforementioned data demonstrate that it is likely not realistic to expect patients on oral isotretinoin to consistently take the medications with the FDA recommended highcalorie and high-fat diets. Even if clear drug administration instructions are given and understood, patients may dismiss the instructions or forget them over the course of treatment, especially if not repeatedly emphasized. In addition, physicians may feel uncomfortable recommending such an unhealthy diet to their patients. By ingesting oral isotretinoin on an empty stomach or with a meal of insufficient fat or calories, patients may experience decreased absorption of the dose and fluctuations in drug plasma levels.5 Over time, this can lead to decreased cumulative exposure to isotretinoin therapy and impact therapeutic outcome, including long-term success.5 Patients who do not achieve the target cumulative dose are more likely to relapse and require subsequent courses of isotretinoin therapy.4,10,11
By eliminating the “food dependence†factor of oral isotretinoin, Absorica LD has the potential to improve patient adherence and achieve overall better therapeutic outcomes. Absorica LD achieves consistent serum levels irrespective of gastrointestinal contents.18 Because of this, adolescents and young adults, with their poor and irregular eating habits, will be relieved from planning doses around concomitant ingestion of food. Busy adults can also have inconsistent eating habits that have to adapt to varying work and personal life schedules, so they may also benefit from a treatment that is not food dependent. Importantly, diets that are either high in protein or low in calorie, which are not conducive for absorption of traditional isotretinoin, can be followed on Absorica LD without potential therapeutic consequence. Patients have the ability to engage in a healthier diet while on oral isotretinoin medication and still maintain adequate dose levels. Physicians can also recommend a healthier diet to their patients on Absorica LD, and they will no longer be obligated to continuously emphasize the importance of co-administration with food throughout the duration of treatment.
Safety Profile
Absorica LD is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients.15 Because of significant adverse reactions associated with its use, Absorica LD should
