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Recreational drug user preferences: Egalet® opioids have low abuse and tampering attractiveness relative to marketed opioids
S60
Abstracts Ò
(342) Recreational drug user preferences: Egalet opioids have low abuse and tampering attractiveness relative to marketed opioids
(344) Improvements in fibromyalgia symptoms are sustained for 1 year with milnacipran treatment: results from 2 double-blind, dose-controlled extension studies
C Andersen, P Høyrup Hemmingsen, K Lindhardt, K Schoedel, E Sellers; Kendle Early Phase, Toronto, Ontario, Canada Misuse of opioids intended for chronic treatment of pain is an increasing problem worldwide and extensive abuse of high-dose sustained-release products such as OxyContinÒ has been reported. We have developed a tamper-resistant extended-release dosage form that is difficult to crush, extract or chew. In this study the relative attractiveness of 3 opioid products using this technology (EgaletÒ oxycodone, EgaletÒ morphine and EgaletÒ hydrocodone) were compared to 7 marketed opioid products. This single-session, non-interventional study included 20 recreational opioid users with tampering experience. 10 opioid products were presented to subjects using standardized information cards and photographs: 3 EgaletÒ opioid products; immediate-release morphine and oxycodone [MS IRÒ, Oxy IRÒ], controlled -release morphine [MS ContinÒ] and [KadianÒ]; sustained-release oxycodone [OxyContinÒ]; hydrocodone/acetaminophen [VicodinÒ]; ratioÒ-fentanyl transdermal patch. Assessments included ranking of Overall Desirability; Estimation of Street Value, Opiate Attractiveness Scale; Value of Product Scale; Likelihood to Tamper Scale and open-ended questions about tampering potential. No subjects rated any of the 3 new products as 1st, 2nd or 3rd in Overall Desirability. Preliminary results showed that most subjects (85%) ranked OxyContinÒ as 1st, 2nd or 3rd in Overall Desirability, followed by Oxy IRÒ and MS ContinÒ (55% each). Most subjects (75%) ranked EgaletÒ oxycodone as 8th, 9th or 10th in Overall Desirability followed by EgaletÒ morphine, EgaletÒ hydrocodone (60% each), and then ratioÒ-fentanyl patch (40%). No subjects ranked OxyContinÒ or MS ContinÒ 8th, 9th or 10th in Overall Desirability. Results for Estimated Street Value were similar. Data suggest that EgaletÒ opioids are less attractive to recreational opioid users than existing opioid products. (Supported by Egalet a/s.)
R Ferrera, R Palmer, Y Wang, R Gendreau; Forest Research Institute, Jersey City, NJ Fibromyalgia (FM) is a condition characterized by persistent generalized pain, fatigue, sleep disturbances and cognitive dysfunction. Medications providing sustained relief of these symptoms are important to improve quality of life in FM patients. Milnacipran’s efficacy has previously been established in 2 double-blind, placebo-controlled FM trials (Study 1, 27 weeks, N = 888; Study 2, 15 weeks, N = 1196). Patients completing these studies were eligible for enrollment in corresponding extension studies (Study 1A, N = 449; Study 2A, N = 384) designed to evaluate the longterm efficacy and safety of milnacipran. Patients were maintained on milnacipran 200 mg/day or re-randomized (from placebo or milnacipran 100 mg/day) at a 1:4 ratio to milnacipran 100 or 200 mg/day for an additional 28 (Study 1A) or 39 (Study 2A) weeks of treatment; patients remained blinded to both lead-in and extension study treatments. Efficacy assessments included 24-hour and weekly VAS recall pain, Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGIC). Patients continuing on milnacipran 200 mg/day during the extension treatment period maintained a consistent reduction in 24-hour recall pain scores, with improvements from lead-in baseline of 46% (Study 1A) and 49% (Study 2A) at the final visit. These patients also maintained their improvements from lead-in baseline on weekly-recall pain scores (Study 1A, 47%; Study 2A, 49%), FIQ total scores (Study 1A, 42%; Study 2A, 38%), and demonstrated PGIC improvements at the final visit. Similar improvements were observed with milnacipran 100 mg/day. Milnacipran treatment was generally well tolerated with no new safety concerns resulting from long-term therapy. The most commonly reported adverse event was nausea, which was generally mild and self-limiting. In addition to confirming milnacipran’s safety, these results indicate that milnacipran is capable of sustained efficacy in treating multidimensional symptoms of fibromyalgia for at least 1 year. (Supported by Forest Laboratories, Inc. and Cypress Bioscience, Inc.)
(343) A day-to-day analysis of the analgesic efficacy of milnacipran in the treatment of fibromyalgia
(345) Sexual dysfunction in the chronic pain patient: association with opioid therapy
P Mease, R Palmer, Y Wang, M Hufford; Forest Reserch Institute, Jersey City, NJ The chronic widespread pain that is the hallmark symptom of fibromyalgia (FM) is characterized by marked day-to-day fluctuations in intensity. Thus, an important therapeutic goal is to substantially increase the number of days that FM patients experience pain relief over an extended time. Two double-blind trials previously demonstrated safety and efficacy of milnacipran in FM patients. Using pain data recorded daily from patients using electronic diaries (e-diaries), milnacipran’s day-to-day effects on pain during these 2 studies were examined. FM patients were randomized to receive placebo, milnacipran 100, or 200 mg/day for 27 weeks (Study 1, N = 888) or 15 weeks (Study 2, N = 1196). Pain was assessed by a 24-hour recall VAS pain scale (0-100) collected daily using e-diaries. Days with meaningful pain relief were defined as days that a patient reported $30% or $50% improvements from their mean baseline pain score. The effect of milnacipran treatment versus placebo on the proportion of days with meaningful pain relief was analyzed over the entire 3month treatment period, based on Week 15 observed cases. Patients treated with milnacipran achieved $30% pain reduction in 47% (200 mg/day) and 46% (100 mg/day) of days during the 3-month period compared to 31% for placebo patients (P < .001, both doses) in Study 1, and 45% (200 mg/day) and 44% (100 mg/day) of days compared to 34% for placebo patients (P < .001, both doses) in Study 2. Similarly, milnacipran-treated patients achieved $50% pain reduction in a significantly greater proportion of days over the 3-month period than patients on placebo (Study 1: both doses, 30% vs 17%, respectively; Study 2: 28% and 25% vs 18%, respectively; P < .01, both doses). In conclusion, FM patients treated with milnacipran experienced more days of meaningful pain relief over a 3-month treatment period than patients on placebo. (Supported by Forest Laboratories, Inc. and Cypress Bioscience, Inc.)
H Cassim; Fairview Pain Management Center, Minneapolis, MN Multimodal, interdisciplinary management of chronic pain may include the use of opioids on a long term basis. Despite judicious prescribing of opioid medication, patients using opioids for prolonged periods of time often have undesirable side effects that can impact a variety of systems including sexual function. Though sexual function is a complex interaction of endocrine, neurotransmitter, central nervous and psychological factors, chronic opioid use may have a negative contributory impact. However, data is lacking on the degree to which sexual function is impaired by opioid use. This study was conducted to identify the impact of opioids on sexual function in chronic pain patients. Two hundred male and female pain patients were surveyed in a chronic multidisciplinary pain clinic about their sexual function. Data collection was performed with patient questionnaires. The Brief Male Sexual Function Index (BSFI) and the Female Sexual Function Index (FSFI), both validated scales, were combined to improve the consistency between the sexes and facilitate data analysis. Sexual function was evaluated in terms of desire/sexual drive, arousal, orgasm/ejaculation, problem assessment and overall satisfaction. Each area of sexual function was given a numerical score from 0-4. Category of pain was noted. The type of opioid, dosage and duration of use were identified. Patients were also asked to compare sexual function before and after the use of opioids. Outcome measures will be: Prevalence and types of sexual dysfunction among opioid tolerant and opioid naı¨ve chronic pain patients. Logistic regression analysis will determine correlations between sexual dysfunction and use of opioids, opioid dosage, opioid duration, gender and type of pain.
Abstracts Ò
(342) Recreational drug user preferences: Egalet opioids have low abuse and tampering attractiveness relative to marketed opioids
(344) Improvements in fibromyalgia symptoms are sustained for 1 year with milnacipran treatment: results from 2 double-blind, dose-controlled extension studies
C Andersen, P Høyrup Hemmingsen, K Lindhardt, K Schoedel, E Sellers; Kendle Early Phase, Toronto, Ontario, Canada Misuse of opioids intended for chronic treatment of pain is an increasing problem worldwide and extensive abuse of high-dose sustained-release products such as OxyContinÒ has been reported. We have developed a tamper-resistant extended-release dosage form that is difficult to crush, extract or chew. In this study the relative attractiveness of 3 opioid products using this technology (EgaletÒ oxycodone, EgaletÒ morphine and EgaletÒ hydrocodone) were compared to 7 marketed opioid products. This single-session, non-interventional study included 20 recreational opioid users with tampering experience. 10 opioid products were presented to subjects using standardized information cards and photographs: 3 EgaletÒ opioid products; immediate-release morphine and oxycodone [MS IRÒ, Oxy IRÒ], controlled -release morphine [MS ContinÒ] and [KadianÒ]; sustained-release oxycodone [OxyContinÒ]; hydrocodone/acetaminophen [VicodinÒ]; ratioÒ-fentanyl transdermal patch. Assessments included ranking of Overall Desirability; Estimation of Street Value, Opiate Attractiveness Scale; Value of Product Scale; Likelihood to Tamper Scale and open-ended questions about tampering potential. No subjects rated any of the 3 new products as 1st, 2nd or 3rd in Overall Desirability. Preliminary results showed that most subjects (85%) ranked OxyContinÒ as 1st, 2nd or 3rd in Overall Desirability, followed by Oxy IRÒ and MS ContinÒ (55% each). Most subjects (75%) ranked EgaletÒ oxycodone as 8th, 9th or 10th in Overall Desirability followed by EgaletÒ morphine, EgaletÒ hydrocodone (60% each), and then ratioÒ-fentanyl patch (40%). No subjects ranked OxyContinÒ or MS ContinÒ 8th, 9th or 10th in Overall Desirability. Results for Estimated Street Value were similar. Data suggest that EgaletÒ opioids are less attractive to recreational opioid users than existing opioid products. (Supported by Egalet a/s.)
R Ferrera, R Palmer, Y Wang, R Gendreau; Forest Research Institute, Jersey City, NJ Fibromyalgia (FM) is a condition characterized by persistent generalized pain, fatigue, sleep disturbances and cognitive dysfunction. Medications providing sustained relief of these symptoms are important to improve quality of life in FM patients. Milnacipran’s efficacy has previously been established in 2 double-blind, placebo-controlled FM trials (Study 1, 27 weeks, N = 888; Study 2, 15 weeks, N = 1196). Patients completing these studies were eligible for enrollment in corresponding extension studies (Study 1A, N = 449; Study 2A, N = 384) designed to evaluate the longterm efficacy and safety of milnacipran. Patients were maintained on milnacipran 200 mg/day or re-randomized (from placebo or milnacipran 100 mg/day) at a 1:4 ratio to milnacipran 100 or 200 mg/day for an additional 28 (Study 1A) or 39 (Study 2A) weeks of treatment; patients remained blinded to both lead-in and extension study treatments. Efficacy assessments included 24-hour and weekly VAS recall pain, Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGIC). Patients continuing on milnacipran 200 mg/day during the extension treatment period maintained a consistent reduction in 24-hour recall pain scores, with improvements from lead-in baseline of 46% (Study 1A) and 49% (Study 2A) at the final visit. These patients also maintained their improvements from lead-in baseline on weekly-recall pain scores (Study 1A, 47%; Study 2A, 49%), FIQ total scores (Study 1A, 42%; Study 2A, 38%), and demonstrated PGIC improvements at the final visit. Similar improvements were observed with milnacipran 100 mg/day. Milnacipran treatment was generally well tolerated with no new safety concerns resulting from long-term therapy. The most commonly reported adverse event was nausea, which was generally mild and self-limiting. In addition to confirming milnacipran’s safety, these results indicate that milnacipran is capable of sustained efficacy in treating multidimensional symptoms of fibromyalgia for at least 1 year. (Supported by Forest Laboratories, Inc. and Cypress Bioscience, Inc.)
(343) A day-to-day analysis of the analgesic efficacy of milnacipran in the treatment of fibromyalgia
(345) Sexual dysfunction in the chronic pain patient: association with opioid therapy
P Mease, R Palmer, Y Wang, M Hufford; Forest Reserch Institute, Jersey City, NJ The chronic widespread pain that is the hallmark symptom of fibromyalgia (FM) is characterized by marked day-to-day fluctuations in intensity. Thus, an important therapeutic goal is to substantially increase the number of days that FM patients experience pain relief over an extended time. Two double-blind trials previously demonstrated safety and efficacy of milnacipran in FM patients. Using pain data recorded daily from patients using electronic diaries (e-diaries), milnacipran’s day-to-day effects on pain during these 2 studies were examined. FM patients were randomized to receive placebo, milnacipran 100, or 200 mg/day for 27 weeks (Study 1, N = 888) or 15 weeks (Study 2, N = 1196). Pain was assessed by a 24-hour recall VAS pain scale (0-100) collected daily using e-diaries. Days with meaningful pain relief were defined as days that a patient reported $30% or $50% improvements from their mean baseline pain score. The effect of milnacipran treatment versus placebo on the proportion of days with meaningful pain relief was analyzed over the entire 3month treatment period, based on Week 15 observed cases. Patients treated with milnacipran achieved $30% pain reduction in 47% (200 mg/day) and 46% (100 mg/day) of days during the 3-month period compared to 31% for placebo patients (P < .001, both doses) in Study 1, and 45% (200 mg/day) and 44% (100 mg/day) of days compared to 34% for placebo patients (P < .001, both doses) in Study 2. Similarly, milnacipran-treated patients achieved $50% pain reduction in a significantly greater proportion of days over the 3-month period than patients on placebo (Study 1: both doses, 30% vs 17%, respectively; Study 2: 28% and 25% vs 18%, respectively; P < .01, both doses). In conclusion, FM patients treated with milnacipran experienced more days of meaningful pain relief over a 3-month treatment period than patients on placebo. (Supported by Forest Laboratories, Inc. and Cypress Bioscience, Inc.)
H Cassim; Fairview Pain Management Center, Minneapolis, MN Multimodal, interdisciplinary management of chronic pain may include the use of opioids on a long term basis. Despite judicious prescribing of opioid medication, patients using opioids for prolonged periods of time often have undesirable side effects that can impact a variety of systems including sexual function. Though sexual function is a complex interaction of endocrine, neurotransmitter, central nervous and psychological factors, chronic opioid use may have a negative contributory impact. However, data is lacking on the degree to which sexual function is impaired by opioid use. This study was conducted to identify the impact of opioids on sexual function in chronic pain patients. Two hundred male and female pain patients were surveyed in a chronic multidisciplinary pain clinic about their sexual function. Data collection was performed with patient questionnaires. The Brief Male Sexual Function Index (BSFI) and the Female Sexual Function Index (FSFI), both validated scales, were combined to improve the consistency between the sexes and facilitate data analysis. Sexual function was evaluated in terms of desire/sexual drive, arousal, orgasm/ejaculation, problem assessment and overall satisfaction. Each area of sexual function was given a numerical score from 0-4. Category of pain was noted. The type of opioid, dosage and duration of use were identified. Patients were also asked to compare sexual function before and after the use of opioids. Outcome measures will be: Prevalence and types of sexual dysfunction among opioid tolerant and opioid naı¨ve chronic pain patients. Logistic regression analysis will determine correlations between sexual dysfunction and use of opioids, opioid dosage, opioid duration, gender and type of pain.