MSD Receives European Approval of its Atypical Antipsychotic Medication SYCREST® (asenapine) for the Treatment of Manic Episodes in Bipolar I Disorder


WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–MSD (MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A). announced today that the European Commission has approved the Marketing Authorization Application (MAA) for SYCREST® (asenapine) sublingual tablets for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. Today’s decision was based on recommendations from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The Commission Decision applies to all 27 European Member States.

“Today’s approval provides a new treatment for patients in Europe that is intended to help address the needs of one of the most serious mental illnesses.”

“Bipolar I disorder is difficult to manage, and patients frequently discontinue therapy for a variety of reasons,” said Eduard Vieta, M.D., Ph.D., professor of psychiatry at the University of Barcelona, and director of the Bipolar Disorders Program of the Hospital Clinic, Barcelona, Spain. “Having multiple treatment options is vital for patients, and asenapine represents a new option for this serious disease.”

The European Commission approval of SYCREST, an atypical antipsychotic, for the treatment of manic episodes in bipolar I disorder, was based on a review of efficacy data from a clinical trial program, which included nearly 1,300 patients with bipolar mania. SYCREST is marketed as SAPHRIS® (asenapine) sublingual tablets in the United States.

Clinical Trial Overview

Efficacy of SYCREST was demonstrated in two similarly-designed, three-week, randomized, double-blind, placebo- and active-controlled (olanzapine) monotherapy trials of adult patients who had bipolar I disorder with an acute manic or mixed episode with or without psychotic features. Asenapine demonstrated superior efficacy to placebo in the reduction of manic symptoms over three weeks. A statistically significant difference between asenapine and placebo was seen as early as day two.

These pivotal short-term studies were extended via a nine-week, double-blind, non-inferiority study to assess maintenance of efficacy and safety for up to 12 weeks. Maintenance of effect during the episode after 12 weeks of randomized treatment was observed. These studies were further extended for 40 weeks to assess safety for up to a total 52 weeks.

Additionally, efficacy of SYCREST as adjunctive therapy to the mood stabilizers lithium or valproate was demonstrated in a 12-week, placebo-controlled trial involving 326 patients with a manic or mixed episode of bipolar I disorder, with or without psychotic features. The addition of asenapine as adjunctive therapy in patients who were partially non-responsive to lithium or valproate monotherapy for two weeks at therapeutic serum levels resulted in superior reduction of manic symptoms versus lithium or valproate alone at weeks three and 12.

“SYCREST reflects MSD’s ongoing commitment to innovative therapies in the area of neuroscience,” said Armin Szegedi, M.D., head of Psychiatry, Neuroscience Clinical Research, Merck. “Today’s approval provides a new treatment for patients in Europe that is intended to help address the needs of one of the most serious mental illnesses.”

Approximately 4,500 subjects, including more than 3,150 patients in phase II/III studies, have contributed to asenapine’s safety and tolerability data. In clinical studies, asenapine was generally well tolerated. The most common side effects seen in more than 10% of patients included somnolence and anxiety. Other common side effects seen in between one and 10 patients per 100 included weight gain, increased appetite, dystonia (slow or sustained muscle contractions), akathisia (restlessness), dyskinesia (involuntary muscle contractions), parkinsonism (slow movements, tremor), sedation, dizziness, dysgeusia (change in taste), oral hypoaesthesia (numb feeling of the tongue or in the mouth), increase in alanine aminotransferase (liver protein levels), muscle rigidity, and fatigue. SYCREST is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

In the combined short-term and long-term SYCREST trials, the mean change in body weight for asenapine was 0.8 kg. The proportion of subjects with clinically significant weight gain (≥ 7 % weight gain from baseline at endpoint) in the short-term bipolar mania trials was 6.5% for asenapine compared to 0.6% for placebo.

About Bipolar I Disorder

Bipolar I disorder (also known as manic depression) is a chronic, episodic illness characterized by mania (episodes of elevated moods, extreme irritability, decreased sleep and increased energy), depression (overwhelming feelings of sadness, suicidal thoughts), or a combination of both.

Important Safety Information

Elderly patients with dementia-related psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic substances are at an increased risk of death. Sycrest is not approved for the treatment of patients with dementia-related psychosis and is not recommended for use in this particular group of patients.

Neuroleptic Malignant Syndrome

Neuroleptic Malignant Syndrome (NMS), characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels, has been reported to occur with antipsychotics, including asenapine. Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure. If a patient develops signs and symptoms indicative of NMS Sycrest must be discontinued.

Seizures

In clinical trials, cases of seizure were occasionally reported during treatment with asenapine. Therefore, Sycrest should be used with caution in patients who have a history of seizure disorder or have conditions associated with seizures.

Suicide

The possibility of a suicide attempt is inherent in psychotic illnesses and bipolar disorder and close supervision of high-risk patients should accompany treatment.

Orthostatic hypotension

Asenapine may induce orthostatic hypotension and syncope, especially early in treatment, probably reflecting its α1-adrenergic antagonist properties. Elderly patients are particularly at risk for experiencing orthostatic hypotension. In clinical trials, cases of syncope were occasionally reported during treatment with Sycrest. Sycrest should be used with caution in elderly patients and in patients with known cardiovascular disease (e.g., heart failure, myocardial infarction or ischemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the patient to hypotension (e.g., dehydration and hypovolemia).

Tardive dyskinesia

Medicinal products with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical, involuntary movements, predominantly of the tongue and/or face. In clinical trials, cases of tardive dyskinesia were occasionally reported during treatment with asenapine. The onset of extrapyramidal symptoms is a risk factor for tardive dyskinesia. If signs and symptoms of tardive dyskinesia appear in a patient on Sycrest, discontinuation of treatment should be considered.

Hyperprolactinaemia

Increases in prolactin levels were observed in some patients with Sycrest. In clinical trials, there were few adverse reactions related to abnormal prolactin levels reported.

QT interval

Clinically relevant QT prolongation does not appear to be associated with asenapine. Caution should be exercised when Sycrest is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicinal products thought to prolong the QT interval.

Hyperglycaemia and diabetes mellitus

Hyperglycaemia or exacerbation of pre-existing diabetes has occasionally been reported during treatment with asenapine. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia or bipolar disorder and the increasing incidence of diabetes mellitus in the general population. Appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.

Dysphagia

Esophageal dysmotility and aspiration have been associated with antipsychotic treatment. Cases of dysphagia were occasionally reported in patients treated with Sycrest.

Body temperature regulation

Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic medicines. From the clinical trials, it is concluded that clinically relevant body temperature dysregulation does not appear to be associated with asenapine. Appropriate care is advised when prescribing Sycrest for patients who will be experiencing conditions that may contribute to an elevation in core body temperature, e.g. exercising strenuously, exposure to extreme heat, receiving concomitant medicinal products with anticholinergic activity or being subject to dehydration.

Patients with severe hepatic impairment

Asenapine exposure is increased 7-fold in patients with severe hepatic impairment (Child-Pugh C). Therefore, Sycrest is not recommended in such patients.

Parkinson’s disease and dementia with Lewy bodies

Physicians should weigh the risks versus the benefits when prescribing antipsychotic medicinal products, including Sycrest, to patients with Parkinson’s disease or dementia with Lewy Bodies (DLB) since both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotics. Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.

Drug Interactions

Caution should be used when asenapine is taken in combination with other centrally acting medicinal products. Patients should be advised to avoid alcohol while taking SYCREST. Additionally, SYCREST should be co-adminsitered cautiously with fluvoxamine (a CYP1A2 inhibitor) and with medicinal products that are both substrates and inhibitors of CYP2D6 (e.g., paroxetine).

For full prescribing information, please refer to the Summary of Product Characteristics.

About MSD

Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships.

Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2009 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

SYCREST® is a registered trademark of N.V. Organon, a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A

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