An international pharmaceutical group headquartered in Milan, Italy, and with an international presence, Recordati has been improving healthcare and developing and distributing innovative products for nearly 100 years. Recordati focuses mainly on treatments for rare diseases, cardiovascular, and urological disorders.
IIn 2013, Recordati purchased a drug portfolio of 10 drugs for rare (and other) diseases from the Danish-owned Lundbeck for $100 million, the journal Genetic Engineering and Biotechnology News publishes. This portfolio of medications is for distribution in the United States by the Recordati Rare Disease Unit, which is a wholly owned US corporation, in an attempt to solidify the company’s entry into the oncology and hematology fields as close to half of the drugs that are approved for rare diseases fall into these categories.
Recordati Rare Diseases has three main marketed products (Carbaglu, Panhematin, and NeoProfen) and several others in their repertoire as well. Specifics of some of the top Recordati pharmaceutical products are outlined below:
- Carbaglu (carglumic acid): treatment for NAGS deficiency and high blood ammonia levels
- Panhematin (hemin for injection): treats reoccurring acute intermittent porphyria (AIP), which is related to the menstrual cycle of affected women
- NeoProfen (ibuprofen lysine) injection: a treatment for premature infants to close a patent ductus arteriosus
- CHEMET (succimer): capsules to treat lead poisoning in children
- Urispas/Genurin (flavoxate): for overactive bladders; a Recordati-developed and proprietary pharmaceutical product
- Tranxene T-Tab (clorazepate dipotassium tablets): a benzodiazepine drug for the treatment of anxiety
- Cosmegen for injection (dactinomycin): an injection to treat urologic cancers like those of the bladder and kidneys
- Mustargen (mechlorethamine HCl for injection): to treat hematologic cancers, such as leukemia and lymphomas as well as thoracic and respiratory cancers
- Indocin (indomethacin) IV: a cardiac drug to treat cardiac arrhythmias and heart disorders
Recordati also developed lercanidipine (a high blood pressure drug marketed as Zanidip) and fenticonazole (an antifungal disease for vaginal thrush) and holds them as proprietary pharmaceuticals. They are marketed today in many countries but are, as of yet, commercially unavailable in the United States. Recordati helps to develop and market many pharmaceutical products in specialty fields of healthcare, including for rare diseases.
Desoxyn (Methamphetamine) Available via Prescription
Another product marketed by the Recordati Rare Diseases group is Desoxyn, which is a prescription and tablet form of methamphetamine. Desoxyn is prescribed to treat exogenous obesity and attention deficit hyperactivity disorder (ADHD). Due to the high abuse and dependency rate of methamphetamine, Desoxyn is prescribed sparingly and generally only to individuals who are resistant to other forms of treatment. In 2012, only 16,000 methamphetamine prescriptions were dispensed in the United States, the Drug Enforcement Administration (DEA) reports. More common for ADHD are Adderall (a combination of amphetamine and dextroamphetamine) and Ritalin (methylphenidate). These drugs are typically tried before resorting to Desoxyn for ADHD.
Desoxyn is a stimulant drug that helps those suffering from ADHD to focus and concentrate better. Stimulants also increase energy levels while decreasing the need to sleep and suppressing appetite. Functions of the autonomic central nervous system are heightened by stimulant drugs, elevating heart rate, body temperature, blood pressure, and respiration rates. In someone suffering from ADHD, methamphetamine may help to keep the brain and body regulated.
The DEA classifies Desoxyn, and methamphetamine, as a Schedule II controlled substance, which is the most stringent regulation for a drug with accepted medical use and value. The only substances classified higher (in Schedule I) are those that are considered illegal within the United States (e.g., heroin, LSD, ecstasy, etc.). Methamphetamine may be diverted from licit channels but is more often manufactured in clandestine laboratories, often using over-the-counter (OTC) cold medications like pseudoephedrine (Sudafed). Desoxyn tablets may be chewed, or crushed and then snorted, smoked, or injected when abused.
Methamphetamine produces a euphoric rush, or “high,” when it is abused. The high can be intense, and use of the drug can cause the brain to get used to the chemical changes it makes, leading to tolerance. Individuals will then need to take higher doses to keep feeling the positive effects. Before long, a dependence on methamphetamine can build up, and difficult withdrawal symptoms and drug cravings can occur when the drug is not active in the bloodstream. For this reason, when Desoxyn is prescribed for licit reasons, it is generally only for a short period of time and under close supervision of a medical professional (also usually in conjunction with other therapeutic methods as well). Abuse of Desoxyn can be dangerous and has many unwanted side effects, including addiction.
Desoxyn Dependence and Addiction
When someone takes Desoxyn for medical purposes, the doses are typically as low as possible. The goal is for the drug to be effective while attempting to minimize the potential for developing a dependence or experiencing an intoxicating high. Desoxyn interacts with parts of the brain responsible for regulating pleasure and energy. The intense high that Desoxyn, and methamphetamine, can produce make it extremely vulnerable to abuse and also make the drug highly addictive.
It can become difficult to stop taking the drug as cravings for it and difficult withdrawal symptoms can occur as it processes out of the body. Methamphetamine (meth) withdrawal symptoms are largely emotional in nature, although physical symptoms develop as well. During withdrawal from meth, individuals often feel depressed and anxious; have trouble sleeping; are irritable, restless, and agitated; feel mentally and physically exhausted; and often feel disoriented within about 12 hours or so after the last dose, the National Highway Traffic Safety Association (NHTSA) reports. Heart rate, body temperature, and blood pressure can become irregular during withdrawal, and appetite changes are common. Compulsive drug use and a loss of control over dosage can set in. The National Survey on Drug Use and Health (NSDUH) publishes that in 2014, more than a half-million Americans were currently using methamphetamine for nonmedical purposes at the time of the survey, and this is considered drug abuse.
Mood swings, aggression, stunted growth, and cardiac complications are further potential adverse side effects of Desoxyn as is the potential for a fatal overdose when mixed with other drugs (or alcohol) or when it is taken in higher doses than prescribed. An overdose can lead to circulatory collapse, blood pressure and heart rate irregularities, tremors, rapid breathing, convulsions, hallucinations, stomach upset, nausea and vomiting, sweating, aggression and combativeness, mental confusion, panic attacks, and restlessness. A “crash” often follows the high of a stimulant drug like methamphetamine, leaving individuals feeling “hollowed out,” tired, hungry, and depressed.
Methamphetamine may do long-term damage to the brain, the National Institute on Drug Abuse (NIDA) warns, when it used for a length of time as well, impacting movement, memory, learning, and motivation as well as other cognitive functions. Tooth decay, skin picking and subsequent irritation, infection, and sores, unhealthy weight loss, paranoia, and possible psychosis can occur in people who abuse meth for regularly for a long time as well. Some of these negative side effects may be reversible with abstinence; however, some of the effects on the brain may not completely heal even when the drug processes out of the body, and meth is no longer active in the system.
The multiple negative possible side effects coupled with the allure of abuse and the high rate of dependence and addiction, make Recordati’s Desoxyn a relatively under prescribed drug, even though it does have some medically accepted uses.