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1 US Department of Justice Drug Enforcement U.S. Department of Justice Drug Enforcement Administration Schedule of Controlled Substances: Placement of Serdexmethylphenidate into Schedule IV Background, Data, and Analysis: Eight Factors Determinative of Control and Findings Pursuant to 21 U.S.C. 812(b) Prepared by Diversion Control Division, Drug and Chemical Evaluation Section Washington, D.C. 20537 April 2021 1 I. Background Serdexmethylphenidate chloride (SDX), chemically known as 3-[[[(1S)-1-carboxy-2- hydroxyethyl]-amino]carbonyl]-1-[[[[(2R)-2-[(1R)-2-methoxy-2-oxo-1-phenylethyl]-1- piperidinyl]carbonyl]oxy]methyl]pyridinium chloride, is a new molecular entity with no central nervous system (CNS) activity. It is metabolized in the large intestine to dexmethylphenidate (d- MPH), a schedule II CNS stimulant. Thus, SDX is considered a prodrug of d-MPH. On March 2, 2020, Commave Therapeutics S.A. (Sponsor), in partnership with KemPharm, Inc., submitted to the U.S. Food and Drug Administration (FDA) a new drug application (NDA) for a combination drug product containing SDX and d-MPH, proposed as a treatment for Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older (HHS review, 2021). On March 02, 2021, FDA approved the NDA for AZSTARYS, a combination drug product containing d-MPH and SDX. According to the FDA-approved product label, AZSTARYS capsules contain 28/6, 42/9 or 56/12 mg of serdexmethylphenidate chloride/dexmethylphenidate hydrochloride (equivalent to 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, and 52.3 mg/10.4 mg of serdexmethylphenidate/dexmethylphenidate, respectively)1. The Drug Enforcement Administration (DEA) received, on March 2, 2021, from the Department of Health and Human Services (HHS), a scientific and medical evaluation entitled “Basis for the Recommendation to Control Serdexmethylphenidate and its Salts in schedule IV of the Controlled Substances Act” and a scheduling recommendation (HHS review, 2021). Following consideration of the eight factors and findings related to the substance’s abuse potential, legitimate medical use, and dependence liability, HHS2 recommended that SDX and its salts be controlled in schedule IV of the Controlled Substances Act (CSA) under 21 U.S.C. 812(b). According to the HHS review, SDX has not been marketed in any country for any medical indication. The CSA requires DEA, as delegated by the Attorney General3, to determine whether HHS’s scientific and medical evaluation, HHS’s scheduling recommendation, and all other relevant data constitute substantial evidence that a substance should be scheduled. 21 U.S.C. 811(b). This document is a summarized review of the relevant data, law enforcement information, and determination to control SDX under the CSA. II. Eight Factors Determinative of Control Pursuant to 21 U.S.C. 811(c), DEA must consider eight factors in making any finding of substantial evidence of potential for abuse, including the data and law enforcement information relevant thereto. Factor 1. SDX’s Actual or Relative Potential for Abuse 1 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212994s000lbl.pdf. 2 Administrative responsibilities for evaluating a substance for control under the CSA are performed for HHS by FDA, with the concurrence of the National Institute on Drug Abuse (NIDA), according to a Memorandum of Understanding (50 FR 9518; March 8, 1985). 3 28 CFR 0.100(b). 2 As stated by HHS, SDX is a new drug that has not been marketed in the United States, or any other country. As such, information on the actual abuse of SDX is not available. The term “abuse” is not defined in the CSA. However, the legislative history of the CSA4 suggests using the following four prongs in determining whether a particular drug or substance has a potential for abuse: a) There is evidence that individuals are taking the drug or other substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community; or According to HHS, SDX has not been marketed legally in the United States or in any other country. FDA is not aware of its availability outside the legal channels either in the United States or in any other country. This characteristic of abuse is not applicable (HHS review, 2021). To date there have been no published reports regarding evidence that individuals are taking SDX in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community. b) There is significant diversion of the drug or other substance from legitimate drug channels; or HHS states that SDX is not currently marketed legally, or to their knowledge illegally, in the United States or any other country that they are aware of and there are no known legitimate drug channels from which it can be diverted. Thus, this characteristic of abuse potential is limited as well. DEA notes that there are no reports of law enforcement encounters of SDX in the National Forensic Laboratory Information System (NFLIS)5 database. c) Individuals are taking the drug or substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs; or According to HHS, SDX is currently not yet available or marketed in the United States, or any country that HHS is aware of and therefore, there is limited information to assess this characteristic of abuse potential (HHS review, 2021). To date there have been no published reports regarding evidence that individuals are taking SDX on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer SDX. d) The drug is a new drug so related in its action to a drug or other substance already listed as having a potential for abuse to make it likely that the drug substance will have the same potential for abuse as such drugs, thus making it reasonable to assume that there may be significant diversion from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community. As mentioned in the HHS review and discussed more fully in Factor 2, clinical studies show that SDX produces effects that are similar to other stimulant drugs in schedule IV, such as 4 Comprehensive Drug Abuse Prevention and Control Act of 1970, H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970) reprinted in U.S.C.C.A.N. 4566, 4603. 5 The National Forensic Laboratory Information System (NFLIS) is a national forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by State and local forensic laboratories in the United States. NFLIS data were queried on March 4, 2021. 3 phentermine. The pharmacological mechanism of action of SDX is based on its prodrug characteristics, as it must be metabolized to d-MPH to exert its effects. According to HHS, the capacity of orally administered SDX to produce abuse related effects is similar to that of schedule IV stimulant drugs such as phentermine. SDX as compared to d-MPH in clinical studies demonstrated a lower potential for abuse when taken by the intranasal (IN) or intravenous (IV) routes. Data gathered from in vitro binding studies show that SDX does not interact with dopamine or norepinephrine transporters, the primary site of action of d-MPH or with any receptor system known to be a site of action for abuse related effects. Data from in vitro chemical studies demonstrated that under certain experimental conditions, SDX was converted to a pharmacologically inactive metabolite, ritalinic acid. However, SDX was stable in most acidic and basic experimental conditions. SDX is also stable in human plasma, whole blood, stimulated intestinal and gastric fluid, and in human kidney, liver, intestinal and lung S9 fractions as noted in Factor 3. Because SDX is a new molecular entity and not available or marketed in the United States, evidence to date regarding its diversion, illicit manufacturing, or deliberate ingestion is currently lacking. However, as HHS notes (HHS review, 2021), pharmacological data indicates that SDX has a lower abuse potential than its metabolite, d-MPH, a schedule II drug. Data also indicate that SDX is likely to have abuse potential similar to schedule IV stimulants such as phentermine, when taken at supratherapeutic doses by oral route. Thus, it is reasonable to assume that there will be equivalent diversions from legitimate channels of SDX, use contrary to or without medical advice, and a lower capability of creating hazards to users and to the safety of the community. Factor 2. Scientific Evidence of SDX’s Pharmacological Effects According to the HHS review, the pharmacology of SDX may be similar to some stimulant drugs but only via its metabolism in the large intestine to d-MPH. SDX has no CNS activity and is a prodrug of d-MPH (HHS review, 2021). In Vitro Receptor Binding Studies As described in the HHS review, there were two in vitro receptor binding studies conducted by the Sponsor, Study AB54825 and Study AB54826. The first study (Study AB54825) provided the binding profile of SDX at the dopamine (DAT), norepinephrine (NET), and serotonin (SERT) transporters. The second study (Study AB54826) was used to identify binding to any other receptors known to interact with drugs of abuse (HHS review, 2021). In the first study, the binding affinities of SDX were determined at the DAT, NET, and SERT transporters. The binding affinity at the DAT transporter was determined using CHO-S cells expressing human DAT transporters using [125I]-RTI-55 as the radioligand and in the presence of 10 μM nomifensine to estimate non-specific binding as well as a reference control, GBR-12909.
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