MIAMI, FL & JERSEY CITY, NJ, USA I October 15, 2019 I Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced the U.S. Food and Drug Administration (FDA) has approved SECUADO ® (asenapine) transdermal system, the first-and-only transdermal patch formulation for the treatment of adults with schizophrenia.1
“As people living with schizophrenia cycle through treatments their therapeutic options narrow, leaving them and their caregivers looking for new treatment options,” said Leslie Citrome, M.D., M.P.H., Clinical Professor of Psychiatry and Behavioral Sciences, New York Medical College. “In addition to offering a new delivery option, transdermal patches can also provide caretakers and healthcare providers with a non-intrusive, visual confirmation that a treatment is being utilized.”
The once-daily transdermal drug delivery system (TDDS) provides sustained concentrations during wear time (24 hours)2 of the atypical antipsychotic drug asenapine, a well-established treatment for schizophrenia. A transdermal patch may help to mitigate some of the challenges patients face with the management of their schizophrenia.2
“There is an enormous unmet need for new types of schizophrenia treatments, and Noven is committed to giving people living with this devastating disease and their family members new options that may help them effectively manage their symptoms,” said Dr. Naruhito Higo, Chairman and Chief Executive Officer, Noven Pharmaceuticals, Inc. “We commend the FDA on the approval of SECUADO and look forward to bringing it to market in the U.S. as soon as possible so people living with schizophrenia have a transdermal delivery option for asenapine treatment.”
In the international, Phase 3, double-blind, placebo-controlled study, SECUADO achieved the primary endpoint of statistically significant improvement from baseline in the change of the total Positive and Negative Syndrome Scale (PANSS) compared to placebo at week six. Efficacy and safety were assessed during the six-week treatment period in 616 adults living with schizophrenia. Additionally, SECUADO demonstrated statistically significant improvement in Clinical Global Impression-Severity (CGI-S) scores, the key secondary endpoint of the Phase 3 study.
The systemic safety profile of SECUADO was consistent with what is known for sublingual asenapine.1 The most commonly observed adverse reactions were extrapyramidal disorder, application site reaction, and weight gain.1
Please click here for full Prescribing Information, including a Boxed Warning.
What is SECUADO?
SECUADO is a prescription medicine used to treat adults with schizophrenia. SECUADO is a transdermal system (patch) you apply to your skin. It is not known if SECUADO is safe and effective in children less than 18 years of age with schizophrenia.
About Schizophrenia
Schizophrenia is a severe, chronic psychiatric disease with a heterogeneous course and symptom profile. The symptoms associated with schizophrenia are disabling and lifelong, and greatly affect a patient’s quality of life and social functioning. Symptoms usually start between ages 16 and 30 and fall into three categories: positive, negative and cognitive. Positive symptoms are psychotic behaviors not generally seen in healthy people and can include hallucinations, delusions, thought disorders and movement disorders. Negative symptoms are associated with disruptions to normal emotions and behaviors and can include flat affect (reduced expression of emotions), reduced feelings of pleasure in everyday life, difficulty beginning and sustaining activities and reduced speaking. Cognitive symptoms can include poor executive functioning (the ability to understand information and use it to make decisions), trouble focusing or paying attention and problems with working memory (the ability to use information immediately after learning it).3
About Noven
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products. Noven’s mission is to develop and offer pharmaceutical products that meaningfully benefit patients around the world, with a commitment to advancing patient care through transdermal drug delivery. Noven is a stand-alone operating subsidiary of Japan-based Hisamitsu Pharmaceutical Co., Inc., serving as Hisamitsu’s U.S. platform in prescription pharmaceuticals, and helping Hisamitsu bring the benefits of patch therapy to the world. For more information about Noven, visit www.noven.com. For information about Hisamitsu, visit www.hisamitsu.co.jp/english.
1Secuado [prescribing information]. Miami, FL: Noven Therapeutics LLC; 2019.
2Citrome, L, Zeni CM, Correll CU. Patches: Established and Emerging Transdermal treatments in psychiatry. J Clin Psychiatry 2019;90(4):18nr12554.
3National Institute of Mental Health. Schizophrenia. [Internet]. Available from: https://www.nimh.nih.gov/health/statistics/schizophrenia.shtml. Accessed September 2019.
SOURCE: Noven Pharmaceuticals
Post Views: 20
MIAMI, FL & JERSEY CITY, NJ, USA I October 15, 2019 I Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced the U.S. Food and Drug Administration (FDA) has approved SECUADO ® (asenapine) transdermal system, the first-and-only transdermal patch formulation for the treatment of adults with schizophrenia.1
“As people living with schizophrenia cycle through treatments their therapeutic options narrow, leaving them and their caregivers looking for new treatment options,” said Leslie Citrome, M.D., M.P.H., Clinical Professor of Psychiatry and Behavioral Sciences, New York Medical College. “In addition to offering a new delivery option, transdermal patches can also provide caretakers and healthcare providers with a non-intrusive, visual confirmation that a treatment is being utilized.”
The once-daily transdermal drug delivery system (TDDS) provides sustained concentrations during wear time (24 hours)2 of the atypical antipsychotic drug asenapine, a well-established treatment for schizophrenia. A transdermal patch may help to mitigate some of the challenges patients face with the management of their schizophrenia.2
“There is an enormous unmet need for new types of schizophrenia treatments, and Noven is committed to giving people living with this devastating disease and their family members new options that may help them effectively manage their symptoms,” said Dr. Naruhito Higo, Chairman and Chief Executive Officer, Noven Pharmaceuticals, Inc. “We commend the FDA on the approval of SECUADO and look forward to bringing it to market in the U.S. as soon as possible so people living with schizophrenia have a transdermal delivery option for asenapine treatment.”
In the international, Phase 3, double-blind, placebo-controlled study, SECUADO achieved the primary endpoint of statistically significant improvement from baseline in the change of the total Positive and Negative Syndrome Scale (PANSS) compared to placebo at week six. Efficacy and safety were assessed during the six-week treatment period in 616 adults living with schizophrenia. Additionally, SECUADO demonstrated statistically significant improvement in Clinical Global Impression-Severity (CGI-S) scores, the key secondary endpoint of the Phase 3 study.
The systemic safety profile of SECUADO was consistent with what is known for sublingual asenapine.1 The most commonly observed adverse reactions were extrapyramidal disorder, application site reaction, and weight gain.1
Please click here for full Prescribing Information, including a Boxed Warning.
What is SECUADO?
SECUADO is a prescription medicine used to treat adults with schizophrenia. SECUADO is a transdermal system (patch) you apply to your skin. It is not known if SECUADO is safe and effective in children less than 18 years of age with schizophrenia.
About Schizophrenia
Schizophrenia is a severe, chronic psychiatric disease with a heterogeneous course and symptom profile. The symptoms associated with schizophrenia are disabling and lifelong, and greatly affect a patient’s quality of life and social functioning. Symptoms usually start between ages 16 and 30 and fall into three categories: positive, negative and cognitive. Positive symptoms are psychotic behaviors not generally seen in healthy people and can include hallucinations, delusions, thought disorders and movement disorders. Negative symptoms are associated with disruptions to normal emotions and behaviors and can include flat affect (reduced expression of emotions), reduced feelings of pleasure in everyday life, difficulty beginning and sustaining activities and reduced speaking. Cognitive symptoms can include poor executive functioning (the ability to understand information and use it to make decisions), trouble focusing or paying attention and problems with working memory (the ability to use information immediately after learning it).3
About Noven
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products. Noven’s mission is to develop and offer pharmaceutical products that meaningfully benefit patients around the world, with a commitment to advancing patient care through transdermal drug delivery. Noven is a stand-alone operating subsidiary of Japan-based Hisamitsu Pharmaceutical Co., Inc., serving as Hisamitsu’s U.S. platform in prescription pharmaceuticals, and helping Hisamitsu bring the benefits of patch therapy to the world. For more information about Noven, visit www.noven.com. For information about Hisamitsu, visit www.hisamitsu.co.jp/english.
1Secuado [prescribing information]. Miami, FL: Noven Therapeutics LLC; 2019.
2Citrome, L, Zeni CM, Correll CU. Patches: Established and Emerging Transdermal treatments in psychiatry. J Clin Psychiatry 2019;90(4):18nr12554.
3National Institute of Mental Health. Schizophrenia. [Internet]. Available from: https://www.nimh.nih.gov/health/statistics/schizophrenia.shtml. Accessed September 2019.
SOURCE: Noven Pharmaceuticals
Post Views: 20
